The U.S. FDA’s device center disclosed its guidance ambitions for this new fiscal year – a list that includes the usual A and B lists for draft and final guidances. However, the agency now has an “under construction” list of guidance ambitions, the status of which is entirely reliant on the agency’s resources.
Ceribell Inc. launched its initial public offering of more than 10.6 million shares of common stock at $17 and steadily saw the trading value rise, before closing just over $25 on Oct. 11 per share. Ceribell, which developed a portable electroencephalogram for use in intensive care and emergency department settings, expected to gross $180.3 million from the IPO excluding any exercise of the underwriters’ option to purchase additional shares. The IPO will close on Oct. 15.
Glooko Inc. secured a $100 million series F financing to support expansion of its diabetes ecosystem platform, which integrates information from more than 200 devices on a centralized, digital data platform that simplifies care for patients and clinicians. At the same time, the company reported the appointment of Mike Alvarez as CEO.
Abbott Laboratories reported it achieved new major milestones to support the company's growing suite of pulsed field ablation (PFA) solutions in electrophysiology: early completion of enrollment in the VOLT-AF IDE study supporting the Volt PFA system, and the launch of the Focalflex trial to assess the company's Tactiflex Duo ablation catheter, sensor enabled, which will be used in the treatment of patients with paroxysmal atrial fibrillation.
With confidence dropping in doing business with China-affiliated life sciences companies due to the Biosecure Act, one of the companies explicitly named in the U.S. legislation is fighting back. Raising the possibility of a constitutional challenge to the bill, Rade Drmanac, co-founder and chief scientific officer of Complete Genomics Inc., wrote to congressional leaders to urge them to remove the California-based subsidiary of MGI from the bill.
Shiratronics Inc. raised $66 million in an oversubscribed series B financing round to support completion of its recently launched clinical trial to evaluate the safety and efficacy of its neuromodulation device in patients with treatment-resistant chronic migraine.
Rhythm AI Ltd recently became the latest company to receive U.S. FDA clearance for its artificial intelligenc-based software for optimizing Atrial Fibrillation procedures.
The U.S. FDA gave the 510(k) green light to Echo IQ Ltd.’s Echosolv AS for its AI-enabled software as a medical device to be used as a decision support aid in detecting severe aortic stenosis.
It’s hard to know where to start in describing the biopharma applications of the 2024 Nobel Prize in Physics. It was awarded to John Hopfield and Geoffrey Hinton “for foundational discoveries and inventions that enable machine learning with artificial neural networks.”
A digital cognitive assessment developed by Braincheck Inc., Braincheck Assess, proved comparable to the gold-standard Montreal Cognitive Assessment in identifying patients with cognitive impairment in a study published in Frontiers in Psychology.
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