Latest news with #IDAP
Yahoo
29-05-2025
- Business
- Yahoo
HistoSonics' histotripsy system receives early market access authorisation in UK
Amid reports of an acquisition by one of the leading players in the medical device space, HistoSonics' Edison histotripsy system has been granted controlled early limited market access in the UK under an Unmet Clinical Need Authorisation (UCNA). The US company received the UCNA under the UK's Innovative Devices Access Pathway (IDAP), launched by the UK Government in 2023 to help fast-track 'transformative medical technologies' into the healthcare system. Designed for the non-invasive destruction of liver tumours, the Edison system delivers focused ultrasound to target and eliminate cancerous liver tissue. The device received de novo clearance from the US Food and Drug Administration (FDA) in 2023. HistoSonics' president and CEO Mike Blue said the company was 'honoured' to work alongside the National Health Service (NHS) to bring histotripsy to UK patients, many of whom have 'limited options'. He states: 'Securing controlled access through the IDAP pilot programme is a tremendous milestone for HistoSonics and signals clear recognition of our technology's potential to transform healthcare.' HistoSonics' authorisation comes as reports emerge that potential buyers are considering acquiring the company. According to a 1 May report by the Financial Times, HistoSonics is seeking a valuation of more than $2.5bn, with Medtronic, GE HealthCare and Johnson & Johnson (J&J), a longtime backer of HistoSonics, among the interested parties evaluating the business. J&J most recently participated in the company's $102m Series D funding round. HistoSonics was selected for a UCNA under the IDAP programme after the UK Medicines and Healthcare products Regulatory Agency (MHRA) determined that histotripsy devices may provide "public health value" for patients with primary or metastatic liver tumours. Other companies awarded part of a £10m funding package from the MHRA last year to expedite their medical devices' entry onto the UK market included Upfront Diagnostics for a portable blood test, and Lenus Health for an AI-based tool to predict patients' risk of hospitalisation for chronic obstructive pulmonary disease (COPD). Earlier this month, healthcare payor Blue Cross Blue Shield of Michigan (BCBSM) and health plan option Blue Care Network became the first US medical insurer to cover non-thermal histotripsy using HistoSonics' Edison system. "HistoSonics' histotripsy system receives early market access authorisation in UK" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Express Tribune
26-03-2025
- Health
- Express Tribune
K-P hospital renovation project stalls
Despite an advance payment of a significant sum to the Infrastructure Development Authority Punjab (IDAP), the renovation and improvement of infrastructure at district headquarters hospitals in Khyber-Pakhtunkhwa have remained stalled for the past three and a half years. As a result, over Rs1 billion from the Health Department remains tied up due to the delay. The K-P Auditor General has recommended an inquiry and action against the officials responsible for the project's failure. Official sources informed The Express Tribune an agreement was signed between K-P's Health Department and IDAP on June 30, 2021, under which the project was to be executed in two phases. Phase I involved the renovation and repair of 13 DHQ hospitals, while Phase II covered non-teaching hospitals. For this purpose, Rs4.37 billion was allocated for Phase I and Rs11.9 billion for Phase II. Under the agreement, IDAP was required to begin work immediately after receiving 25% of the advance funds. However, despite the Health Department paying Rs1.80 billion, no progress has been made in 3.5 years. The Health Department's financial report for 2023-24 confirmed that the advance payment had been made. In response to the prolonged delay, the Project Steering Committee recommended terminating the project in its meeting on May 3, 2024. Sources cited government disinterest, financial crises in recent years, and poor planning by health department officials as key reasons for the project's failure. Meanwhile, IDAP has refused to return the allocated funds. The Auditor General has urged strict action against those responsible. In a related development, the K-P government has decided to audit the funds of all Medical Teaching Institute (MTI) hospitals and has requested detailed expense reports from them. Officials revealed that preparations are underway to review the accounts, expenses, and financial matters of MTI hospitals since 2018. Once completed, the audit findings will be presented before the cabinet. Additionally, a review of amendments to the MTI Reforms Act 2015 is expected. This will include an assessment of recruitments, funds, vacancies, and projects under the act. Last year, The Express Tribune reported that the health department was facing a severe shortage of doctors and had decided to recall all civil servant medics from the MTIs. Official sources informed The Express Tribune that the health department had solicited information from ten MTI hospitals, including Lady Reading Hospital Peshawar (LRH) regarding this matter.
