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Japanese Pharmaceuticals and Medical Devices Agency

FDA to authorize certain imported respirators for healthcare worker use

March 25, 2020 By Nancy Crotti

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 […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Respiratory Tagged With: Australia Therapeutic Goods Administration, CE Mark, FDA, Health Canada, Japanese Pharmaceuticals and Medical Devices Agency

Japanese regulators approve Abiomed’s Impella heart pumps

September 27, 2016 By Fink Densford

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 […]

Filed Under: Regulatory/Compliance, Structural Heart Tagged With: Abiomed, Japanese Pharmaceuticals and Medical Devices Agency

Japan OKs NuVasive’s Reline spine fixation system

March 9, 2016 By Brad Perriello

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 […]

Filed Under: Regulatory/Compliance, Spine Tagged With: Japanese Pharmaceuticals and Medical Devices Agency, Nuvasive

Japan approves Livanova’s Kora 250 MRI-safe pacemaker

January 28, 2016 By Brad Perriello

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 […]

Filed Under: Regulatory/Compliance, Replacement Heart Valves Tagged With: cyberonics, Japanese Pharmaceuticals and Medical Devices Agency, LivaNova, Sorin Group

Regulators deal WMGI double whammy | Regulatory news for the week of February 9, 2015

February 10, 2015 By MassDevice Contributors Network Leave a Comment

Regulators deal Wright Medical a double whammy

February 3, 2015 by Brad Perriello

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Cohera Medical Inc., Covidien, Federal Trade Commission (FTC), Japanese Pharmaceuticals and Medical Devices Agency, Sorin Group, Tornier Inc., wrightmedical

Jarvik Heart wins Japanese approval for LVAD

December 6, 2013 By Chris Walker

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.

Filed Under: News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Structural Heart Tagged With: Japanese Pharmaceuticals and Medical Devices Agency, Jarvik Heart

PLC Systems lands Japanese OK for RenalGuard trial

October 18, 2013 By Chris Walker Leave a Comment

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.

Filed Under: News Well Tagged With: Clinical Trials, Japanese Pharmaceuticals and Medical Devices Agency, PLC Systems Inc.

Sorin wins Japanese OK for heart valve

December 4, 2012 By MassDevice staff Leave a Comment

Sorin Group

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.

Filed Under: News Well, Replacement Heart Valves Tagged With: Japanese Pharmaceuticals and Medical Devices Agency, Sorin Group

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