Intuitive wins new FDA nod for single port robot; Resmed buys diagnostic facility
Intuitive Surgical received Food and Drug Administration clearance for its da Vinci Single Port surgical system for procedures performed through the anus.
The clearance covers the use of the system for transanal local excision/resection, enabling physicians to reach lesions in the upper rectum without cutting the abdomen, according to the Thursday announcement. Conventional transabdominal rectal resection can require multiple incisions and the removal of the rectum.
Intuitive designed the single port device to navigate narrow body cavities. Physicians can control up to three multi-jointed instruments and a camera through a single entry point.
Intuitive secured clearance for a stapler that works with the system last month, positioning it to step up U.S. commercialization of a robot that is growing quickly overseas.
The company reported 94% single port procedure growth in the first quarter, driven by use in Korea, Europe and Japan.
Resmed said Thursday it has acquired Virtuox, an independent diagnostic testing facility for sleep, respiratory and cardiac conditions.
Virtuox provides home-based diagnostics and patient monitoring for conditions including sleep apnea. Resmed, which sells sleep devices such as continuous positive airway pressure machines, has put primary care physicians who have existing relationships with IDTFs at the center of its response to the approval of Eli Lilly's GLP-1 drug Zepbound in sleep apnea.
Resmed CEO Michael Farrell, who cited Virtuox by name when discussing the strategy in January, has told investors that targeting physicians who work with IDTFs can enable his company to capture demand created by Lilly's entry to the market.
Resmed sells the Nightowl device for diagnosing sleep apnea, but Farrell said the company is agnostic to how patients are tested. The aim is to drive CPAP prescriptions.
Buying Virtuox gives Resmed a bigger role in the diagnostic process that delivers new users of its CPAP machines. The company is not disclosing how much it paid for Virtuox because the acquisition is not material to its financial results.
Precision Neuroscience has appointed John Woock as chief business officer, according to a Thursday announcement. Woock worked at Axonics for 10 years, joining as its 15th employee, but left the company after its $3.7 billion acquisition by Boston Scientific in November.
Axonics generated $110 million in the first year of its commercial launch in the U.S. and grew sales to around $450 million by 2024. Precision, a brain-computer interface company, recently received 510(k) clearance for a device for recording, monitoring and stimulating electrical activity on the surface of the brain.
Michael Mager, Precision's co-founder and CEO, said in a statement that hiring Woock and appointing Konstantinos Alataris to the board of directors will help the company 'plan for scale and widespread impact in coming years.'
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