FDA – Medical Alley Association

FDA

For the Record with Julia Strandberg, Chief Commercial Officer, Pear Therapeutics

Give us Pear Therapeutics’ elevator pitch. At Pear, we are creating Prescription Digital Therapeutics (PDTs), the next generation of therapeutics that use software to directly treat serious disease, alone or in combination with drugs, allowing for optimized, remote care at scale. We sit at the nexus of biotech, tech and medical device, with the aim to redefine […]

U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel), a New CAR T Cell Therapy for Adults with Relapsed or Refractory Large B-cell Lymphoma

PRINCETON, N.J.–(BUSINESS WIRE)– Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large […]

FDA: Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults

U.S. Food and Drug Administration issued the following announcement on Nov. 6. The U.S. Food and Drug Administration permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The […]

FLEX Vessel Prep™ System Receives New Indication to Address In-Stent Restenosis

Minneapolis, MN, October 21, 2020 – VentureMed Group, Inc. (VentureMed), a privately-held medical device innovator in vessel preparation for interventional treatment of peripheral arterial disease (PAD) and stenoses of arteriovenous (AV) fistulas and grafts, announced today that the U.S. Food and Drug Administration (FDA) cleared the Company’s FLEX Vessel Prep™ System for use in the […]

TYPE IIR Surgical Mask Product Announcement

Medical Products HUB announced this week, the launch of its own branded Type IIR Surgical Mask with CE, FDA and TGA (pending) approvals with ISO 9001: 2015; ISO 13485:2016 & ISO 14001:2015.  The Type IIR Mask will be released at a competitive price range of US$0.13 -US$0.11 per piece (based on quantity ordered), which is […]

Element Scales Its Health Sciences Business with ALG Acquisition

London, UK – July 27, 2020 – Element Materials Technology (Element) has acquired industry leading pharmaceutical testing business, Analytical Lab Group (ALG) from Thompson Street Capital Partners, significantly strengthening Element’s market position in pharmaceutical testing in North America and another important step in growing its Life & Health Sciences segment. ALG’s team of 130 scientists […]

Pelvital Announces FDA Clearance of Flyte™, In-Home Pelvic Floor Muscle Treatment for Stress Urinary Incontinence

MINNEAPOLIS, Minnesota – August 20, 2020 – Pelvital, a medical technology company focused on women’s health, announced it has received U.S. Food and Drug Administration (FDA) clearance for Flyte TM, a first-of-its-kind, non-invasive, intravaginal home-use device that is intended for strengthening of the pelvic floor muscles, which has been found to help women with stress […]

Somnetics gains FDA authorization to supply vital non-invasive ventilators in the fight against COVID-19.

MAA COVID-19 INFORMATION DISCLAIMER: The Medical Alley Association is providing COVID-19 related information, including the “COVID-19 Resource Connect” feature on its website and summaries of laws, executive orders, and government programs that may be of interest to members, as a public service.   The Medical Alley Association makes no representations, guarantees, or warranties as to the accuracy, […]

Sterilucent Granted Emergency Use Authorization to Reprocess Respirators

Hydrogen peroxide process enables safe mask reuse April 21, 2020: The U.S. Food and Drug Administration has granted Sterilucent, Inc. (Minneapolis, MN),an Emergency Use Authorization to allow the emergency use of the SterilucentTM HC 80TT Vaporized Hydrogen Peroxide Sterilizer for decontaminating single-use compatible N95 and N95-equivalent respirators. Test results have demonstrated that filtering facepiece respirators may be reprocessed for use […]

DuVal & Associates Help Expedite FDA Submissions

Via DuVal & Associates The FDA regulatory law firm of DuVal & Associates has been participating in the COVID-19 crisis by helping many companies seek FDA Emergency Use Authorizations (EUAs) for ventilators, cannulas, diagnostics, respirator masks, an abbreviated form of approval. The firm has also worked on many other EUA products ancillary and outside of […]

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