Philips has discontinued the U.S. sales of several respiratory device product lines, including one from its much-maligned CPAP portfolio. The company says it agreed with the FDA and the DOJ on the terms of a consent decree focused on the Respironics business. Philips says it provides “clarity and a roadmap” for compliance and the restoration […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
How Philips’ significant respiratory devices recall unfolded
There are 5.5 million recalled CPAPs and other devices — and reports of deaths. Here’s a Philips recall timeline. Philips in mid-2021 kicked off a recall that involved millions of CPAP and BiPAP ventilators and other respiratory devices. The devices — used for sleep apnea therapy and more — had sound abatement foam that could […]
Report: Musk’s Neuralink fined over hazardous materials transport
Neuralink, the Elon Musk-backed brain-computer interface (BCI) maker, was reportedly fined for violating rules related to the movement of hazardous materials. Reuters reports that the company received the penalty for violating U.S. Department of Transportation (DOT) rules. The outlet says DOT investigators found the company failed to register itself as a transporter of hazardous material. […]
CroíValve wins FDA IDE for tricuspid heart valve
CroíValve announced today that it began an early feasibility study for its Duo tricuspid coaptation valve system. The beginning of the study follows FDA investigational device (IDE) approval. Tandem II, a prospective, multi-center, non-randomized, single-arm study looks at the safety and performance of Duo in patients with severe or greater symptomatic tricuspid regurgitation (TR). Duo […]
FDA clears Syngo Virtual Cockpit tech from Siemens Healthineers
Siemens Healthineers announced that the FDA cleared its Syngo Virtual Cockpit, a private, secure communication platform. The platform enables real-time image visualization, acquisition and collaboration between healthcare professionals across multiple sites. Siemens Healthineers designed the software so users can connect to CT, MR, PET and a number of other scanners. Scanners include those made by […]
Intuitive wins CE mark for da Vinci SP surgical robot
Intuitive Surgical announced today that it received CE mark approval for its da Vinci SP surgical robot platform. da Vinci SP, the company’s single-port system, joins the existing X and Xi surgical ecosystem in Europe. Beginning in urology and transoral procedures, European clinicians can grow into additional applications over time. This follows last night’s news […]
Intuitive seeks FDA clearance for its next-gen da Vinci 5
Intuitive Surgical has submitted for FDA 510(k) clearance of its next-generation da Vinci 5 multiport surgical robot. The da Vinci 5 will join Intuitive’s existing da Vinci robotic surgical system portfolio alongside the multiport X and Xi systems and the single-port SP. There is also Ion, Intuitive’s robotic-assisted platform for minimally invasive biopsy in the […]
FDA clears SnoreLessNow mandibular advancement device
SnoreLessNow announced today that the FDA granted 510(k) clearance for its over-the-counter dental device. Known as SomniFit-S in Europe, the Anti-Snore Mouth Guard+ reduces snoring by positioning the jaw gently forward. It allows for increased airflow and eliminates airway obstruction by tissues inside the mouth, requiring no masks, hoses or electronics. Swiss manufacturer Oscimed SA […]
FDA clears Kallisio’s 3D-printed oral insert for radiation therapy
Kallisio recently announced that the FDA has cleared its 3D-printed Stentra, used to protect head and neck cancer patient’s healthy tissue during radiation therapy. Stentra is fabricated of bio-compatible nylon materials (nylon ISO 10993-1), using 3D SLS printing technology. Baltimore-based Kallisio says Stentra directs radiation to the target tumor area while reducing the harmful impact […]
How does medtech CEO compensation compare?
Medtech CEO compensation averaged $10.5 million during the companies’ most recent fiscal years. That number from our recent MassDevice analysis may seem like a lot to an average person — but not as much in the world of corporate CEOs. In fact, the average compensation of S&P 500 company CEOs was $25.2 million in 2022, […]
FDA clears AI-based lung analysis software from Thirona
Thirona announced today that it received FDA 510(k) clearance for the latest update of its AI-based LunQ clinical software. LungQ 3.0.0 utilizes AI to automatically segment the pulmonary segments and subsegments in the internal anatomy of the lung. The analysis includes the identification of structures like lobes, segments, subsegments, airways and fissures. It analyzes the […]