Abiomed (NSDQ:ABMD) said today that it won pre-market approval from the FDA for its Impella RP heart pump, claiming it as the only such device cleared for right heart failure. Like Abiomed’s flagship Impella heart pump, the Impella RP is threaded into the heart via the femoral artery in the thigh. But unlike previous Impella […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Arkis BioSciences wins FDA nod for CerebroFlow neuro cath
Arkis BioSciences said yesterday it won FDA clearance for its CerebroFlow external ventricular drainage catheter. The CerebroFlo catheter is designed for insertion into a ventricular cavity of the brain for external drainage of cerebro spinal fluid, and features the comapny’s Endexo technology designed to reduce obstructions, infections and lower treatment costs, Arkis BioSciences said. “Arkis’ CerebroFlo […]
Stryker wins FDA 510(k) for 3D-printed Tritanium C anterior cervical cage
Stryker (NYSE:SYK) said today it won FDA 510(k) clearance for its Tritanium C 3D-printed anterior cervical cage interbody fusion cage desigend for cervical spinal use. The newly cleared Tritanium C cage is constructed with the company’s Tritanium in-growth technology featuring a highly porous titanium material designed for bone ingrowth and biological fixation. The company claims the […]
Essilor, Luxotica rebuff EU anti-trust regulators
(Reuters) –Luxottica (NYSE:LUX) and Essilor (EPA:EI) have not offered any concessions to allay EU antitrust regulators’ concerns over their proposed 46-billion-euro ($55.2 billion) merger, increasing the possibility of a lengthy EU investigation into the deal. Italian eyewear maker Luxottica, which owns brands such as Ray-Ban and Oakley, and French lens manufacturer Essilor had until Sept. 19 to offer […]
UK warns about alarm failure for Roche’s insulin pumps
The UK’s Medicines and Healthcare products Regulatory Agency issued a medical device alert for Roche‘s (OTC:RHHBY) Accu-Check Insight insulin pumps today, warning that the device’s audible and vibration alarms may not function. If a user doesn’t see the notification message on the pump and can’t hear or feel an alarm, it could lead to hyperglycemia, the agency said. […]
Mazor Robotics wins CE Mark for Mazor X surgery platform
Mazor Robotics (NSDQ:MZOR) said today that it won CE Mark approval in the European Union for its Mazor X robot-assisted surgery platform, setting the stage for strategic backer Medtronic (NYSE:MDT) to put the device on the European market. “Receipt of the CE Mark is an important step in our plan to expand the patient, surgeon and hospital benefits […]
China has a new medical device classification catalog: what you need to know
Grace Fu Palma, China Med Device The China Food and Drug Administration (CFDA) recently unveiled its new “Medical Device Classification Catalogue” – which has significant implications for medical devices registrations or renewals. The new catalog, announced Aug. 31 after a previous draft release and feedback period, goes into effect in less than a year – on Aug. 1, 2018. Read the […]
Medtech complaint handling: Is there something to complain about?
Medtech complaint handling appears to be a work in process, according to Sparta Systems’s recent quality management market survey. The 2017 survey – which had 148 respondents in highly regulated industries including medical devices (23%) – found that nearly a quarter of those who answered did not have a well-defined and adopted complaint handling process. Read […]
MiMedx files IND for Ph2 AmnioFix osteoarthritis trial
MiMedx (NSDQ:MDXG) said today that it filed an IND with the FDA for a Phase II trial of its AmnioFix product in patients with osteoarthritis of the knee. The 318-patient study is designed to compare the safety and efficacy of MiMedx’s micronized dehydrated human amnion/chorion membrane (dHACM) injection with a 0.9% sodium chloride USP placebo injection. […]
Pentax Medical wins CE Mark for DEC duodenoscope
Hoya‘s Pentax Medical said today it won CE Mark approval in the European Union for its DEC duodenoscope featuring a disposable elevator cup. The Tokyo-based company said the new device features a combination of advanced cleaning capabilities and improved infection prevention controls to ensure a more reliable performance. The new device also features improved high definition […]
Mevion files for FDA clearance for S250i proton therapy system
Mevion Medical Systems said yesterday it submitted a 510(k) premarket notification to the FDA for its Mevion S250i proton therapy system with Hyperscan pencil beam scanning tech. The Mevion S250i features improved pencil beam scanning fields and Hyperscan pencil beam scanning tech to allow for faster energy layer switching, the Littleton, Mass.-based company said. “We focused […]