The U.S. Securities and Exchange Commission (SEC) has issued the final order concluding an action against Baxter International Inc. over the company’s use of accounting mechanisms to produce gains by manipulating foreign exchange transactions. While these activities are said to have been undertaken entirely at the behest of only two employees, the agreement will cost Baxter $18 million and serves as a cautionary tale about a lack of supervision of employees charged with managing company funds.
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.
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.
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.
Insightec Ltd. broadened its CE mark approval for the Exablate Neuro, a focused ultrasound platform which treats essential tremors, to allow patients to have their second side treated. With some 60 million people estimated to be affected by essential tremor globally, Insightec hopes that with both sides treated, patients will have full body relief from tremor and therefore be able to resume everyday activities.
Choosing blastocysts for transfer based on size could give prospective parents a much better chance of success in welcoming a new member to the family, a study published in the Nature portfolio journal Scientific Reports demonstrates.
The U.K. government continues to pump money into research projects focusing on the use of artificial intelligence (AI) in health care as it looks to technology to help diagnose and treat patients. It provided £2 million (US$2.5 million) in funding to test innovative ways to tackle cancers with poor survival rates.
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