medical device guru

Diagnostics & Healthcare News

Qorvo Biotechnologies Receives FDA Emergency Use Authorization for Rapid COVID-19 Antigen Testing

Qorvo, a leading provider of innovative radio frequency (RF) solutions that connect the world, today announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Qorvo Omnia™ SARS-CoV-2 Antigen Test. The test is...

April 18, 2021

Diagnostics & Healthcare News

ZOLL Medical Corporation Acquires Respicardia

ZOLL Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, today announced that it has acquired Respicardia, Inc., a provider of novel implantable neurostimulators for the treatment of moderate to severe Central Sleep Apnea (CSA)....

April 18, 2021

Diagnostics & Healthcare News

Donisi Wins De Novo Clearance for Contact-Free AI System that Spots Changes in Heart, Breathing Patterns

The U.S. Food and Drug Administration (FDA) has granted Donisi‘s revolutionary contact-free multiparameter measurement system de novo clearance, making Donisi the first to bring this innovative technology to the medical market. “I’m really proud of our team; we developed a medical device that...

April 11, 2021

Diagnostics & Healthcare News

OpSens Announces Closing of $28.75 Million Bought Deal Public Offering Including $3.75 Million Over-Allotment Option Exercised in Full

OpSens Inc. (“OpSens” or the “Company”) (TSX:OPS) (OTCQX:OPSSF) announced last week the closing of its previously announced bought deal public offering (the “Offering”) of common shares of the Company (the “Common Shares”), for total gross proceeds of approximately $28,750,000. The Company...

February 28, 2021

Diagnostics & Healthcare News

FDA clears Signifier Medical’s Electric Tongue Muscle Strengthener to Treat Sleep Apnea and Snoring

The FDA has approved eXciteOSA, the revolutionary first-ever daytime treatment for mild obstructive sleep apnea and snoring. Used for only 20 minutes per day for a period of six weeks and then twice per week, the therapy is clinically proven...

February 21, 2021

Diagnostics & Healthcare News

CLEW Medical Receives FDA Clearance for AI-Based Software that Predicts Hemodynamic Instability

CLEW Medical, a leader in AI-powered predictive analytics, today announced that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance and authorized the use of “CLEWICU,” CLEW’s artificial intelligence (AI) based ICU solution, to predict hemodynamic instability in...

February 7, 2021

Diagnostics & Healthcare News

Inovytec’s Small “Sparrow” Ventilators Receive FDA Clearance

Inovytec, an innovator of multi-functional and user-friendly critical medical devices, announced today that it was granted FDA 510(k) clearance to market and sell its Ventway Sparrow ventilators in the United States. The ventilators are already commercialized in Europe, Canada and Australia and undergoing registration procedures...

February 7, 2021

Diagnostics & Healthcare News

FDA Approves Boston Scientific’s Vercise Genus Deep Brain Simulation System

Boston Scientific Corporation has received U.S. Food and Drug Administration approval of its fourth-generation Vercise Genus Deep Brain Stimulation (DBS) System. The portfolio, approved for conditional use in a magnetic resonance imaging (MRI) environment, consists of a family of Bluetooth-enabled,...

January 30, 2021

Diagnostics & Healthcare News

STERIS Spending $4.6B to Acquire Cantel Medical

STERIS plc (NYSE: STE) (“STERIS” or the “Company”) and Cantel Medical Corp (NYSE:CMD) (“Cantel”) today announced that STERIS has signed a definitive agreement to acquire Cantel, through a U.S. subsidiary.  Cantel is a global provider of infection prevention products and...

January 14, 2021