Medical Devices

AI-Powered Algorithm Gets FDA 501(k) Clearance for Detection of Subarachnoid Hemorrhages

03/04/2022

A recent study found that Viz ANEURYSM had a 94 percent accuracy rate of diagnosing subarachnoid hemorrhages on computed tomography angiography (CTA). Excerpt from the Press Release: Subarachnoid hemorrhages reportedly affect nearly 30,000 Americans each year and have a 40 percent mortality rate. However, Viz ANEURYSM, a new artificial intelligence (AI)-powered algorithm, may improve the…

Read More

Ra Medical Systems Provides an Update on Enrollment in Its Pivotal Atherectomy Clinical Trial

02/28/2022

Excerpt from the Press Release: CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE American: RMED), a medical device company focused on developing its excimer laser system to treat vascular diseases, announces enrollment has reached 95 subjects in its pivotal clinical trial to evaluate the safety and effectiveness of the DABRA excimer laser system as an atherectomy…

Read More

Theradaptive Wins Additional FDA Breakthrough Designation for Spinal Fusion

02/22/2022

Excerpt from the Press Release: FREDERICK, Md. and BOSTON, Feb. 15, 2022 /PRNewswire/ — Theradaptive, a privately held biopharmaceutical company pioneering a new class of regenerative implants announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Medical Device designation for its OsteoAdapt SP Spinal Fusion implant indicated for posterolateral spinal fusion to treat degenerative disc disease, spondylolisthesis,…

Read More

atHeart Medical Receives FDA Approval for the Second Phase of the ASCENT ASD U.S. IDE Trial

02/15/2022

Company’s reSept™ ASD Occluder Aims to Evolve Septal Closure with its Novel Metal-Free Frame Design Excerpt from the Press Release: BAAR, Switzerland and SANTA CLARA, Calif., Feb. 8, 2022 /PRNewswire/ — atHeart Medical, a medical device company dedicated to establishing the new standard of care for closure of atrial septal defects (ASD), today announced it has received approval for the start…

Read More

Rakuten Medical and Karkinos Healthcare Announce Strategic Partnership to Expand the Reach of Novel Cancer Care in India

10/26/2021

Excerpt from the Press Release: SAN MATEO, Calif. and MUMBAI, India, Oct. 21, 2021 /PRNewswire/ — Rakuten Medical Inc, and Karkinos Healthcare Private Limited announced a strategic collaboration to expand the reach of novel cancer care to India. This includes a minority stake acquisition in Karkinos Healthcare by Rakuten Medical. Rakuten Medical’s investment marks Karkinos Healthcare’s first international investor. Rakuten…

Read More

Arch Therapeutics Provides Corporate Update

10/21/2021

90-Day Report Card for Commercialization Effort Excerpt from the Press Release: FRAMINGHAM, Mass., Oct. 13, 2021 (GLOBE NEWSWIRE) — Arch Therapeutics, Inc. (OTCQB: ARTH) (“Arch” or the “Company”), a marketer and developer of novel self-assembling wound care and biosurgical devices, today provided a corporate update at the LD Micro Main Event XIV investor conference in…

Read More

Arch Therapeutics Announces Appointment of Larry Hicks to the Board

10/06/2021

Brings deep industry experience to support commercialization plan Excerpt from the Press Release: FRAMINGHAM, Mass., Sept. 30, 2021 (GLOBE NEWSWIRE) — Arch Therapeutics, Inc. (OTCQB: ARTH) (“Arch” or the “Company”), a marketer and developer of novel self-assembling wound care and biosurgical devices, today announced the appointment of Larry Hicks to its Board of Directors. Mr.…

Read More

Pliant Therapeutics Reports Positive Interim Results from Phase 2a PET Imaging Clinical Trial in Patients with Idiopathic Pulmonary Fibrosis

09/16/2021

Excerpt from the Press Release: – Single dose administration of PLN-74809 achieved αvβ6 target engagement up to 98% in the lungs of IPF patients – All doses achieved target engagement above the threshold for predicted anti-fibrotic activity, with an observed dose-response relationship – PLN-74809 reached highly fibrotic regions of the lung and was bound to αvβ6 in IPF…

Read More

An expert’s guide to developing medical devices

06/07/2021

Excerpt from the Article: When it comes to designing and building novel medical devices to meet the needs of patients and healthcare systems, developers should rely on the core skills of engineering and design to inform their process. But there are “lessons learned” that are unique to the medical device development process. The team at Goddard has…

Read More

SeaSpine Announces Agreement to Acquire 7D Surgical

03/25/2021

Excerpt from the Press Release: CARLSBAD, Calif., March 22, 2021 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today that it has entered into an agreement to acquire all of the issued and outstanding shares of 7D Surgical, Inc.,…

Read More