Ossdsign AB will abandon its 3D-printed cranial reconstructive implant business to focus on U.S. sales of its Ossdsign Catalyst, an off-the-shelf nanosynthetic bone graft that offers gross margins of 90% or better. The new strategy sharply reduces the capital required before the company projects achieving a cash-flow positive position.
Artificial intelligence (AI) is an increasingly common matter of medical practice and thus not just another buzzword, and the U.K. National Institute for Health and Care Excellence (NICE) has opened a program for evidence generation for the use of AI to contour external beam radiotherapy to the tumor of treatment.
In another boost to its diabetes portfolio, Medtronic plc was granted CE mark approval for its Simplera continuous glucose monitor (CGM) sensor. The EU greenlight for Simplera follows the U.S. FDA approval for Medronic’s Minimed 780G insulin pump system earlier in the year. Simplera is an all-in-one disposable CGM sensor which features a two-step insertion process and will help patients who must have multiple daily injections (MDI) manage their diabetes.
Medtech Europe has on several occasions given voice to concerns about the drawn-out overhaul of the European Union’s medical device regulation but has come up with a new set of recommendations to break the regulatory logjam.
The U.K.’s Competition Appeal Tribunal has rejected appeals by drugmakers, including Actavis plc and Allergan Inc., against a ruling by regulators that they hiked the price of a life-saving adrenal insufficiency drug excessively for almost a decade, saddling the companies with fines amounting to nearly £130 million (US$159 million).
With a waiting list of some 90,000 people, startup company Charco Neurotech Ltd. is seeing growing demand for its Cue1 device which has shown to reduce the symptoms of Parkinson’s disease in patients suffering from the condition. The Cue1 is a non-invasive device that can literally change the day-to-day lives of people living with Parkinson's, Lucy Jung, CEO and co-founder of Charco, told BioWorld.
Genflow Biosciences plc has received correspondence from Belgium’s Federal Agency for Medicines and Health Products (FAHMP) with a recommendation to initiate a phase I/II trial of GF-1002 in patients with nonalcoholic steatohepatitis (NASH), rather than in healthy volunteers.
Spybiotech Ltd. has filed a clinical trial application (CTA) with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to evaluate SPYVLP-01, a vaccine targeting human cytomegalovirus (CMV) using its hepatitis B virus-like-particle platform technology.
Atamyo Therapeutics SAS has filed a clinical trial application (CTA) in Europe for ATA-200, its gene therapy targeting γ-sarcoglycan (SGCG)-related limb-girdle muscular dystrophy type 2C/R5 (LGMD-R5).
Chronic rhinitis is drawing more attention from medical device makers in recent years, with solutions including cryotherapy and temperature-controlled radiofrequency disruption of posterior nasal nerves to halt the condition.
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