Latest news with #ISO13485
Yahoo
2 days ago
- Business
- Yahoo
CORE Industrial Partners Portfolio Company PrecisionX Group Acquires Hudson Technologies
CHICAGO, July 16, 2025--(BUSINESS WIRE)--CORE Industrial Partners ("CORE"), a manufacturing, industrial technology, and industrial services-focused private equity firm, announced today the acquisition of Hudson Technologies ("Hudson" or the "Company"), a provider of specialty deep and shallow drawn stamping, by CORE portfolio company PrecisionX Group ("PrecisionX"). The highly complementary addition of Hudson to the PrecisionX platform continues CORE's intent to build a mission-critical precision components business serving attractive end markets. Formed in 2023, PrecisionX offers specialty deep and shallow drawn and progressive stamping as well as Swiss screw, CNC, and wire EDM machining technologies for growth-oriented end markets, including aerospace & defense, medical devices, and satellite & space. The platform covers approximately 400,000 square feet of manufacturing space with more than 650 employees across seven facilities. The Company holds ISO 9001, ISO 13485, and AS9100D certifications, in addition to ITAR and FDA registrations. Founded in 1940, Hudson offers precision deep and shallow drawn stamping and progressive die stamping to manufacture metal enclosures, headers, diaphragms, and components using a variety of materials, from aluminum, stainless steel, copper, brass and titanium to specialty alloys, including Hastelloy, Haynes 242, HyMu80, Inconel, Kovar and Monel, among others. The Company augments its core stamping capabilities with dedicated in-house tool & die design and development as well as a broad selection of value-added finishing services, including annealing, anodizing, bead blasting, heat treating, painting, plating, polishing, and powder coating. Hudson serves numerous end markets, including semiconductor, electronics, and industrials, with especially deep experience in the medical and aerospace & defense sectors. The Company has manufactured deep drawn mission-critical implantable medical devices, such as cardioverter defibrillators and neuromodulation products, for approximately five decades, and produces valves, sensors, diaphragms, housings, antenna, and actuators for aerospace & defense applications ranging from engine and flight control to communication and navigation. Headquartered in Ormond Beach, Florida, with approximately 150 machines, the Company holds an AS9100 certification and an ITAR registration. Matthew Puglisi, Partner at CORE, said, "We believe Hudson, a long-recognized provider of deep and shallow drawn stamping, is an especially strong strategic fit with the PrecisionX platform. In addition to enhancing PrecisionX's specialty stamping capabilities and capacity, the acquisition deepens the platform's medical and aerospace & defense presence while aligning with its strategic focus on serving critical-use applications in those attractive end markets." Rock Lambert, Operating Partner at CORE, said, "It's a pleasure to welcome Hudson to the PrecisionX platform. We believe Hudson's impressive customer base of many industry-leading companies in demanding end markets speaks to both the Company's differentiated manufacturing capabilities and its stringent focus on quality, both of which are a compelling fit with the platform." ABOUT CORE INDUSTRIAL PARTNERS: CORE is an industrials-focused private equity firm with more than $1.58 billion in total limited partner capital commitments across four funds investing in North American lower middle-market manufacturing, industrial technology, and industrial service businesses. With offices located in Chicago, Austin and Cleveland, CORE's team is comprised of highly experienced former CEOs and investment professionals with shared beliefs, deep experience, and a demonstrated track record of building market-leading businesses. Through our capital, insight, and operational expertise, CORE partners with families, entrepreneurs and management teams and strives to build best-in-class companies. For more information, visit ABOUT PRECISIONX GROUP: PrecisionX Group provides precision metal components for critical-use applications in growth-oriented end markets, including aerospace & defense, medical devices, satellite & space, electric vehicles, mining, semiconductors, and other industrial markets. Headquartered in Waterbury, Connecticut, PrecisionX utilizes deep and shallow drawn and progressive stamping, as well as Swiss screw, CNC, and wire EDM machining technologies to manufacture high-precision components from prototyping through high-volume production. For more information, visit ABOUT HUDSON TECHNOLOGIES: Hudson Technologies provides precision deep and shallow drawn stamping and progressive die stamping, in-house tool & die design and development capabilities, and a broad selection of value-added finishing services. The Company serves a variety of end markets, including aerospace & defense, medical, electronics, semiconductor, and industrials through a fleet of approximately 150 machines. Headquartered in Ormond Beach, Florida, the Company holds an AS9100 certification and is ITAR-registered. For more information, visit View source version on Contacts Jeremy MilnerGregory FCAjmilner@ (401) 862-9422 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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Business Standard
4 days ago
- Business
- Business Standard
Cipla buys 20% stake in iCaltech to broaden respiratory device portfolio
Cipla on Monday announced that it has entered into definitive agreements to acquire a 20 per cent stake in Bengaluru-based iCaltech Innovations, through an investment of approximately ₹5 crore in optionally convertible preference shares and one equity share. The transaction is expected to be completed within a month, subject to customary closing conditions. The investment aligns with Cipla's strategy to strengthen its presence in the respiratory care space, particularly in the diagnostics segment. iCaltech, an ISO 13485 certified medical device company, is engaged in the design, development, manufacturing, and commercialisation of diagnostic products, with a core focus on respiratory applications. Achin Gupta, Global COO, Cipla, said, 'Our decision to invest in iCaltech reflects Cipla's commitment to advancing respiratory diagnostics. As lung leaders with the aim to reduce the existing gap in the current ecosystem, our strategic funding will enable iCaltech to further expand and develop innovative devices.' Cipla said the deal would enable it to partner with iCaltech in developing integrated healthcare solutions by leveraging synergies between pharmaceuticals and medical device technologies. Under the terms, iCaltech will continue to operate independently, while Cipla will hold 20 per cent voting rights post-investment. iCaltech recorded a revenue of ₹6.7 crore in FY25, up from ₹4.19 crore in FY24 and ₹1.28 crore in FY23. The acquisition is part of Cipla's broader focus on expanding its devices, diagnostics, and digital offerings, especially in its core respiratory portfolio.
Business Wire
16-07-2025
- Business
- Business Wire
CORE Industrial Partners Portfolio Company PrecisionX Group Acquires Hudson Technologies
CHICAGO--(BUSINESS WIRE)--CORE Industrial Partners ('CORE'), a manufacturing, industrial technology, and industrial services-focused private equity firm, announced today the acquisition of Hudson Technologies ('Hudson' or the 'Company'), a provider of specialty deep and shallow drawn stamping, by CORE portfolio company PrecisionX Group ('PrecisionX'). The highly complementary addition of Hudson to the PrecisionX platform continues CORE's intent to build a mission-critical precision components business serving attractive end markets. Formed in 2023, PrecisionX offers specialty deep and shallow drawn and progressive stamping as well as Swiss screw, CNC, and wire EDM machining technologies for growth-oriented end markets, including aerospace & defense, medical devices, and satellite & space. The platform covers approximately 400,000 square feet of manufacturing space with more than 650 employees across seven facilities. The Company holds ISO 9001, ISO 13485, and AS9100D certifications, in addition to ITAR and FDA registrations. Founded in 1940, Hudson offers precision deep and shallow drawn stamping and progressive die stamping to manufacture metal enclosures, headers, diaphragms, and components using a variety of materials, from aluminum, stainless steel, copper, brass and titanium to specialty alloys, including Hastelloy, Haynes 242, HyMu80, Inconel, Kovar and Monel, among others. The Company augments its core stamping capabilities with dedicated in-house tool & die design and development as well as a broad selection of value-added finishing services, including annealing, anodizing, bead blasting, heat treating, painting, plating, polishing, and powder coating. Hudson serves numerous end markets, including semiconductor, electronics, and industrials, with especially deep experience in the medical and aerospace & defense sectors. The Company has manufactured deep drawn mission-critical implantable medical devices, such as cardioverter defibrillators and neuromodulation products, for approximately five decades, and produces valves, sensors, diaphragms, housings, antenna, and actuators for aerospace & defense applications ranging from engine and flight control to communication and navigation. Headquartered in Ormond Beach, Florida, with approximately 150 machines, the Company holds an AS9100 certification and an ITAR registration. Matthew Puglisi, Partner at CORE, said, 'We believe Hudson, a long-recognized provider of deep and shallow drawn stamping, is an especially strong strategic fit with the PrecisionX platform. In addition to enhancing PrecisionX's specialty stamping capabilities and capacity, the acquisition deepens the platform's medical and aerospace & defense presence while aligning with its strategic focus on serving critical-use applications in those attractive end markets.' Rock Lambert, Operating Partner at CORE, said, 'It's a pleasure to welcome Hudson to the PrecisionX platform. We believe Hudson's impressive customer base of many industry-leading companies in demanding end markets speaks to both the Company's differentiated manufacturing capabilities and its stringent focus on quality, both of which are a compelling fit with the platform.' ABOUT CORE INDUSTRIAL PARTNERS: CORE is an industrials-focused private equity firm with more than $1.58 billion in total limited partner capital commitments across four funds investing in North American lower middle-market manufacturing, industrial technology, and industrial service businesses. With offices located in Chicago, Austin and Cleveland, CORE's team is comprised of highly experienced former CEOs and investment professionals with shared beliefs, deep experience, and a demonstrated track record of building market-leading businesses. Through our capital, insight, and operational expertise, CORE partners with families, entrepreneurs and management teams and strives to build best-in-class companies. For more information, visit ABOUT PRECISIONX GROUP: PrecisionX Group provides precision metal components for critical-use applications in growth-oriented end markets, including aerospace & defense, medical devices, satellite & space, electric vehicles, mining, semiconductors, and other industrial markets. Headquartered in Waterbury, Connecticut, PrecisionX utilizes deep and shallow drawn and progressive stamping, as well as Swiss screw, CNC, and wire EDM machining technologies to manufacture high-precision components from prototyping through high-volume production. For more information, visit Hudson Technologies provides precision deep and shallow drawn stamping and progressive die stamping, in-house tool & die design and development capabilities, and a broad selection of value-added finishing services. The Company serves a variety of end markets, including aerospace & defense, medical, electronics, semiconductor, and industrials through a fleet of approximately 150 machines. Headquartered in Ormond Beach, Florida, the Company holds an AS9100 certification and is ITAR-registered. For more information, visit
Time of India
05-07-2025
- Health
- Time of India
State gets CDSCO-notified medical device audit body
Visakhapatnam: Andhra Pradesh is now home to its first-ever CDSCO-notified auditing body for medical devices. In a significant move, the Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, has notified KIHT Certification Services (KCS) as the state's first regulatory body authorised to inspect manufacturing facilities for Class A and Class B medical devices . Among 14 such notified bodies nationwide, KCS is the only one currently operational in Andhra Pradesh and Telangana, marking a major milestone in the region's quality management capabilities. Founded in July 2017, the Kalam Institute of Health Technology (KIHT)-housed inside the AMTZ campus-is a Government of India project supported by the Department of Biotechnology. It promotes and supports innovations in medical technologies through research and development, industry promotion, policymaking, and knowledge management. Established in April 2022, KCS is accredited by the National Accreditation Board for Certification Bodies and offers comprehensive services including ISO 13485 certification , quality systems audits, risk management training, and CE-mark consultancy-making it a full-service hub for manufacturers seeking to meet global regulatory standards. This approval brings immediate benefits to domestic manufacturers, particularly MSMEs, by eliminating the need for audits outside the state-resulting in significant time and cost savings.
Yahoo
26-06-2025
- Business
- Yahoo
Avvio Medical Proudly Announces ISO 13485 Certification, Marking a Major Milestone in Global MedTech Readiness
SAN FRANCISCO, June 26, 2025--(BUSINESS WIRE)--Avvio Medical, Inc., a clinical-stage medical device company focused on transforming the treatment of kidney stone disease, is proud to announce that it has successfully achieved ISO 13485:2016 certification following its initial audit conducted by BSI (British Standards Institution). This globally recognized certification demonstrates Avvio's compliance with international standards for medical device quality management systems and reflects the company's unwavering commitment to excellence, patient safety, and operational rigor. "This milestone is more than a regulatory requirement—it represents the fulfillment of our promise to stand up a full-scale medical device company," said Paul Molloy, CEO of Avvio Medical. "Through disciplined execution, a culture of continuous improvement, and a mindset grounded in honor, behavioral integrity, and precision, we have built a foundation for scalable, global operations." He added, "The quality culture at Avvio is not just a box-checking exercise. We embed it through storytelling, structured messaging, and principles drawn from disciplines of Lean and KAIZEN and a culture Bushidō. As we shared with the BSI audit team, our internal motto is #ImproveEverything—and this certification illustrates that we live by it." The ISO 13485 certification now enables Avvio to fully qualify its manufacturing and design processes for commercial scaling, pursue CE marking for international distribution, and reinforce confidence among global partners, investors, and regulators. The achievement is a major step toward the company's upcoming 2026 commercial launch in the U.S. market. With this certification, Avvio affirms that it is not only compliant—but built to lead. About the Enhanced Lithotripsy System (ELS) The AVVIO ELS introduces microbubble enhanced acoustic cavitation lithotripsy that enables kidney stone treatments to move out of the traditional operating room and into more accessible outpatient and office-based settings. The system provides a single, minimally invasive therapy suitable for Ambulatory Surgery Centers (ASCs) and cystoscopy suites, without requiring general anesthesia, fluoroscopy, or costly capital equipment. This innovation offers compelling clinical and economic advantages for both patients and providers. About Avvio Medical Avvio Medical is a privately held medical technology company based in San Francisco and dedicated to transforming the treatment of urinary stones. Its breakthrough platform is designed to improve patient experience, reduce healthcare costs, and expand access to care by offering a fast, minimally invasive solution suitable for a wide range of clinical settings. The company's system eliminates the routine need for general anesthesia or X-ray imaging, streamlining the treatment pathway for both patients and healthcare professionals. View source version on Contacts Media Contact: Paul MolloyChief Executive OfficerAvvio Medical, Tel: (415) 887-2037
