The FDA said yesterday that certain imported respirators (FFRs) may be eligible for emergency use authorization (EUA) to protect public health and safety during the coronavirus outbreak. The FDA said these these devices, imported from Australia, Brazil, Europe, Japan, Korea and Mexico, may be effective in protecting healthcare workers from airborne COVID-19 particulates, “based on […]
Japanese Pharmaceuticals and Medical Devices Agency
Japanese regulators approve Abiomed’s Impella heart pumps
Abiomed (NSDQ:ABMD) said today that it won approval from the Japanese Ministry of Health, Labor & Welfare’s Pharmaceuticals & Medical Devices Agency for its Impella line of heart pumps. The Danvers, Mass.-based company said its devices are the “1st and only percutaneous temporary ventricular support devices” to win Japanese PMDA approval and be deemed safe and effective […]
Japan OKs NuVasive’s Reline spine fixation system
NuVasive Inc. (NSDQ:NUVA) said today that it’s planning a launch later this year for its Reline posterior fixation system in Japan, after winning Shonin approval there. The approval is the final hurdle to launching NuVasive’s Integrated Global Alignment platform in Japan, the company said. “Japan’s exceptional growth over the last 3 years demonstrates the clear benefit of […]
Japan approves Livanova’s Kora 250 MRI-safe pacemaker
LivaNova (NSDQ:LIVN) said today that it won Japanese approval for its Kora 250 MRI-safe pacemaker line. The Japanese Pharmaceuticals and Medical Devices Agencyapproval for the Kora 250 SR and Kora 250 DR devices covers full-body MRI scans, London-based LivaNova said. The company was formed by the $2.7 billion merger of Sorin Group and Cyberonics last year. “In collaboration with […]
Regulators deal WMGI double whammy | Regulatory news for the week of February 9, 2015
Jarvik Heart wins Japanese approval for LVAD
Jarvik Heart said it won pre-market approval from the Japanese Pharmaceuticals & Medical Devices Agency for its Jarvik 2000 heart, a left ventricular-assist device.
New York-based Jarvik Heart said the device is the smallest LVAD approved for long-term use in Japan.
PLC Systems lands Japanese OK for RenalGuard trial
PLC Systems (OTC:PLCSF) won approval from the Japanese Ministry of Health, Labor & Welfare for a clinical trial of its RenalGuard device.
Sorin wins Japanese OK for heart valve
Sorin Group (BIT:SRN) said it plans to launch its Mitroflow heart valve in Japan now that a regulatory body there has approved its use.
The Japanese Pharmaceuticals and Medical Devices Agency OK’d the aortic pericardial heart valve, which is surgically implanted to replace the aortic valve in patients with aortic stenosis, according to a press release.
