News
Philips warns not to use certain nebulizers in Trilogy Evo ventilator recall
3+ hour, 26+ min ago (172+ words) Using non-pneumatic nebulizers with the ventilators can lead to under-delivery of therapy to patients, the company said. Philips" Trilogy Evo ventilators provide invasive and noninvasive ventilation, and can be used at home or during patient transport. Philips sent customers a…...
UK steps up push to align medtech regulations with the US
1+ day, 11+ hour ago (258+ words) Health regulators on both sides of the Atlantic are assessing alignment opportunities and exploring mutual recognition mechanisms. Prompted by the finalization of the U.S.-U.K. pharmaceutical partnership, the MHRA shared an update on its efforts to deepen cooperation with the FDA on…...
J&J launches enhanced PFA device in Europe
1+ day, 5+ hour ago (213+ words) The Varipulse Pro pulsed field ablation platform, which has received a CE mark, will be a focus at the upcoming European Heart Rhythm Association annual meeting in Paris. J&J's Varipulse device competes with Boston Scientific's Farapulse and Medtronic's PulseSelect…...
Zimmer hires chief science, technology and medical affairs officer
1+ day, 3+ hour ago (382+ words) Zimmer hires chief science, technology and medical affairs officer'MedTech Dive Don't miss tomorrow's medtech industry news Zimmer hires chief science, technology and medical affairs officer Jonathan Vigdorchik, an orthopedic surgeon from the Hospital for Special Surgery, previously was chief medical…...
VDyne secures FDA nod to start pivotal trial for tricuspid valve
2+ day, 11+ min ago (330+ words) VDyne secures FDA nod to start pivotal trial for tricuspid valve'MedTech Dive Don't miss tomorrow's medtech industry news VDyne secures FDA nod to start pivotal trial for tricuspid valve With approval to study the transcatheter replacement device in patients with…...
Merit Medical acquires View Point for $140M
6+ day, 5+ hour ago (314+ words) View Point sells tumor tissue localization devices that could complement Merit's existing presence in the sector. View Point markets the OneMark Detection Imaging System and OneMark Tissue Markers. Physicians place the devices, which are cleared by the Food and Drug…...
Distalmotion targets ASC robotic gynecology programs with FDA filing
1+ week, 1+ hour ago (201+ words) The company is seeking clearance in additional gynecological indications to support outpatient use of its surgical robot. Distalmotion CEO Greg Roche said in a statement that "expanding gynecology capabilities in outpatient environments represents an important next step in the evolution…...
CMR Surgical robot builds momentum ahead of US rollout
1+ week, 6+ day ago (154+ words) The company is formally introducing its Versius robot at a surgeons" meeting this week in what CEO Massimiliano Colella described as a "watershed moment" for the company. As more surgical robots are cleared in the U.S. " including Medtronic"s Hugo system,…...
Alcon abandons effort to purchase LENSAR after FTC scrutiny
3+ week, 1+ day ago (211+ words) The Federal Trade Commission said the transaction had threatened to raise prices and stifle innovation for cataract laser eye surgery systems. Alcon and LENSAR announced the deal a year ago. At the time, Alcon said it would pay up to…...
Advita Ortho receives warning letter related to shoulder system
3+ week, 6+ day ago (232+ words) Advita Ortho was formed after orthopedic implant maker Exactech sold its assets in bankruptcy. The FDA sent the warning letter after an inspection of Exactech's Sarasota, Florida, facility in July. At the time of the inspection, Exactech had not yet…...