New York AG Forges Deal for Naloxone Nasal Spray Device January 3, 2020 “Starting today, additional companies will be able to gain access to these nasal spray devices,” the AG said. Read More
Masimo Gains Additional FDA Clearance for RD SET Sensor December 31, 2019 The device reduces severe retinopathy neonates. Read More
FDA Reclassifies Electrotherapies for Anxiety and Insomnia December 27, 2019 The agency also requires premarket approval applications for CES devices intended to treat depression. Read More
FDA Approves CryoLife’s Trial for Heart Valve December 26, 2019 The company’s heart valve is the only mechanical valve that is FDA approved and CE Marked for use with significantly less doses of warfarin. Read More
Bayer Gets FDA Expanded Clearance for CT Injection System December 25, 2019 The system flags tumor tissue that may be missed with a standard mammogram. Read More
FDA Grants 510(k) Clearance for Augmedics’ AR Surgical System December 25, 2019 The device accurately tracks the position of surgical tools. Read More
Life Spine’s Titanium Spacer Cleared by FDA December 25, 2019 Surgeons may choose to use barbs instead of screws, which employ teeth and a threaded head to simplify removal. Read More
IRRAS Nabs CE Mark for IRRAflow Catheter December 20, 2019 With the catheter’s CE Mark, the company is now clear to market IRRAflow in the EU. Read More
FDA Clears Interscope’s EndoRotor for Pulmonary Indications December 20, 2019 The company plans to break into the pulmonary market. Read More
Eko Earns Breakthrough Designation for Heart Failure Screening Algorithm December 20, 2019 The technology gives physicians the capability to detect heart disease earlier in patients. Read More
DiaSorin Gains FDA Clearance for VZV Swab Assay December 19, 2019 The company received the FDA’s clearance for the Simplexa VZV Direct assay in June. Read More
Aleva Earns CE Mark for Brain Stimulation Device December 19, 2019 DirectSTIM’s implant does not require exact positioning, the devicemaker said. Read More