BioSig Technologies (NSDQ:BSGM) said last week that its subsidiary, NeuroClear Technologies, raised nearly $4 million in an initial seed-funding round. NeuroClear said it intends to use the proceeds from the $3.7 million round to fund product development and initial pre-clinical studies, development of its intellectual property portfolio and for general corporate purposes. Founded in November 2018, […]
EBR Systems wins FDA breakthrough nod for Wise CRT wireless pacer
EBR Systems said today that it has received breakthrough device designation from the FDA for its Wise CRT system for the treatment of heart failure. Sunnyvale, Calif.-based EBR Systems’ Wise system is a wireless pacer designed to improve the heart’s pumping ability by synchronizing the left and right ventricles to distribute blood to the lungs […]
Baxter puts up $230m for Cheetah Medical
Baxter (NYSE:BAX) said today that it plans to acquire non-invasive hemodynamic monitoring technologies provider Cheetah Medical for a price that could exceed $200 million. Deerfield, Ill.-based Baxter said will pay $190 million for Cheetah Medical upfront, with the potential for an additional $40 million based on clinical and commercial milestones. The acquisition will provide Baxter with […]
J&J’s DePuy Synthes launches Attune cementless knee
Johnson & Johnson’s (NYSE:JNJ) DePuy Synthes division said today it is launching the Attune cementless knee in a rotating platform option in select markets around the world. This launch combines the proprietary technologies of the Attune knee designed to provide stability while the knee is in motion with DePuy Synthes’ background in rotating platform knees […]
Keranova raises $26.5 million for ophthalmic surgical robot
Ophthalmic surgery device maker Keranova said today that it has raised $26.5 million (€24 million) in a second round of financing,. Long-standing shareholders Mérieux Equity Partners and Supernova Invest led the round, joined by Financière Arbevel, Tourrette Investissement and other international investors. Saint-Etienne, France-based Keranova said it will use the money to fund the development […]
New FDA de novo guidance emphasizes complete applications
The FDA has released final guidance to clarify exactly what medtech companies need to include in their requests for the agency to review their applications for de novo approval. The agency said it updated the guidance to comply with the Medical Device User Fee Amendments of 2017 goal to speed the product review process and […]
Masimo wins expanded clearance for O3 oximetry device
Masimo (NSDQ:MASI) said today that its O3 regional oximetry device has been cleared for three additional indices — delta cHb, delta HHb, and delta O2Hb. These indices provide clinicians with greater visibility into changes in the underlying oxyhemoglobin and deoxyhemoglobin components used to calculate cerebral oxygen saturation, or rSO2, the Irvine, Calif.-based company said. The […]
Fractyl touts Revita-2 clinical trial results
Fractyl Laboratories said today that a clinical trial of its Revita DMR therapy for patients with Type 2 diabetes with and without nonalcoholic fatty liver disease (NAFLD) has produced positive results. The Revita-2 trial was a randomized, double-blind, sham-controlled, multicentered study that showed the therapy is safe and effective relative to a sham procedure. Lexington, […]
Medtronic lands reimbursement for MiniMed 670G pump in Germany
Medtronic (NYSE:MDT) said today it has secured reimbursement for its MiniMed 670G insulin pump system from regulators in Germany. The German Federal Association of the Statutory Health Insurances (GKV-SV) granted reimbursement for the smart insulin pump for patients with type 1 diabetes, according to the company. Get the full story on our sister site, Drug Delivery […]
Satsuma Pharmaceuticals registers $75m IPO
Satsuma Pharmaceuticals has registered an initial public offering, seeking to raise $75 million, according to a regulatory filing. The South San Francisco-based company is working on STS101, a nasal powder version of dihydroergotamine for migraine. It intends to use the money to fund its Phase 3 safety and efficacy clinical trials for STS101, manufacturing costs, preparation for […]
Frequency Therapeutics registers $100m IPO
Frequency Therapeutics has registered an initial public offering of common stock worth $100 million. Woburn, Mass.-based Frequency Therapeutics did not disclose the number of shares it seeks to sell or the price range of the offered units. The company applied to the Securities and Exchange Commission have its common stock listed on The Nasdaq Global Market […]
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