Posts by rw-admin
Centinel Spine Announces IDE Approval of Two Different Prodisc C Devices
Centinel Spine said earlier this week that it won an investigational device exemption from the FDA for a clinical trial of its Prodisc cervical disc implants. New York City-based Centinel acquired the Prodisc assets from Johnson & Johnson subsidiary DePuy Synthes in December 2017 for an undisclosed amount. The FDA IDE covers a two-level study of the company…
Read MoreInsightec Receives FDA Approval and CE Mark for Exablate Neuro with GE SIGNA Premier MRI
GE Healthcare, a leader in medical technology and diagnostic and therapeutic imaging, and INSIGHTEC®, a global medical technology innovator of incisionless surgery, today announced FDA approval and CE mark for Exablate Neuro™ compatible with the SIGNA™ Premier MRI system from GE Healthcare. The Exablate Neuro is a focused ultrasound platform for treating deep in the…
Read MoreCenterline Biomedical Receives FDA 510(k) Clearance for Intra-Operative Positioning System
Centerline Biomedical, Inc. (Centerline) has announced that the company has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market its flagship product, the Intra-Operative Positioning System, IOPS. A non-radiation-based surgical navigation system for minimally invasive surgery, IOPS leverages anatomical mapping algorithms and electromagnetic tracking technology to provide three-dimensional color visualization…
Read MoreThese Medical Devices are now Exempt from the 25% China Tariffs
On Tuesday, the U.S. exempted several categories of medical devices from the 25% tariffs imposed on Chinese goods by the Trump administration, including surgical, radiotherapy and dental devices. The Office of the U.S. Trade Representative said the new exclusions are retroactive to July 6, 2018, when tariffs went into effect on some $34 billion in imports…
Read MoreMediCool Technologies Welcomes New CEO to Lead Development of Novel AFib Therapy
Electrophysiology Industry Veteran to Lead Early Stage Commercialization MediCool Technologies, an early stage medical device company developing a novel device to painlessly terminate cardiac arrhythmias, today announced that the Company has appointed Mr. Jeff Rynbrandt as President and Chief Executive Officer. Mr. Rynbrandt brings to the Company 25 year’s leadership across multiple disciplines in both…
Read MoreCritical Innovations Receives Breakthrough Device Designation for FOAM Device
Critical Innovations announced earlier this week that the FDA has granted breakthrough device designation for its “Fast Onset Abdominal Management™ (F.O.A.M.™) device, which is designed to deliver a quickly-expanding foam to tamponade severe internal bleeding in trauma patients. F.O.A.M.™ research and development is supported by funding from U.S. Army Medical Materiel Development Activity (USAMMDA), through…
Read MoreMedtronic Recalls Some Insulin Pumps as FDA Warns They can be Hacked
The U.S. Food and Drug Administration is warning patients and health care providers that certain Medtronic MiniMed insulin pumps are being recalled due to potential cybersecurity risks and recommends that patients using these models switch their insulin pump to models that are better equipped to protect against these potential risks. To date, the FDA is not…
Read MoreMaterialise Receives FDA Clearance for Cardiovascular Planning Software Suite
Materialise, a global 3D printing software and solutions company, has received FDA clearance for its Mimics Enlight cardiovascular planning software suite. The first release will support clinicians planning complex transcatheter mitral valve replacement (TMVR) procedures. Mimics Enlight is based on the strengths of Materialise’s Mimics Innovation Suite, which has helped clinicians produce patient-specific 3D models…
Read MoreRa Medical Launches Large Registry Trial for Peripheral Laser Device
Ra Medical said today that it launched a large registry study to follow patients treated with its laser device for restenosis in the peripheral arteries. Carldbad, Calif.-based Ra Medical’s Dabra device uses laser radiation ablation to bore through blockages in affected arteries. It’s designed to minimize damage to the surrounding vessel tissue. The 2,500-patient Results trial…
Read MoreCorMatrix Cor PATCH for Epicardial Tissue Repair Gets FDA Clearance
CorMatrix® Cardiovascular, Inc., a leading developer of regenerative cardiovascular medical devices, today announced FDA 510(k) clearance for the Cor™ PATCH. The Cor™ PATCH is indicated for epicardial tissue support and repair in adult patients. The Cor™ PATCH epicardial patch is the first epicardial cardiovascular medical device composed of first next generation CorMatrix® ECM® to be…
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