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FDA

Spark Biomedical and Velentium Named ‘Most Innovative’ in Houston

MedTech companies honored at the Houston Business Journal’s third-annual Innovation Awards for life-changing neurostimulation device HOUSTON, TX – October 13, 2021 – Spark Biomedical (Spark) – a Texas-based medical device company and developer of the first drug-free, personalized, wearable solution for opioid withdrawal relief – and Velentium – a professional engineering firm that specializes in the design and manufacturing […]

FDA signs off on change to contraindications for GE’s Optison agent

October 5, 2021 — The U.S. Food and Drug Administration (FDA) has approved the removal of hypersensitivity to blood and blood products from the listed contraindications for GE Healthcare‘s Optison echocardiography contrast agent. As a result, Optison’s prescribing information now only includes a contraindication in patients with known or suspected hypersensitivity to perflutren or albumin. GE said […]

RQM+ MDR Clinical Evaluation Roadmap: An Interview with Jai Kutty

The introduction of MDR caused a major transformation in the medical device industry. Manufacturers continue to grapple with all elements of compliance, but clinical evaluation presents unique challenges. RQM+ is committed to helping clients navigate these challenges with former notified body leaders who understand what reviewers are looking for when evaluating clinical evidence. Introduction to Dr. […]

The Value of Real World Evidence and Secondary Data in MedTech – Part 1 in a Series

Regulators’ Growing Adoption of Real World Evidence Brinda Sriskantha, PhD, Director, Real World Solutions, IQVIA MedTech and Michelle Bulliard, Vice President, Real World Solutions, IQVIA MedTech Regulators have been steadily increasing their use of real world evidence (RWE) to support decision-making. Simultaneously, access to real world data (RWD) continues to increase, and there’s growing clarity […]

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 […]

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