Can Elon Musk’s Neuralink be trusted to put chips in your brain?
Jonathan Raa/NurPhoto via Getty Images.
Billionaire Elon Musk’s brain-computer interface (BCI) company Neuralink successfully completed its first human implant on Sunday (28 January), according to the founder. In a post on X, Musk announced that the patient is recovering well. This is likely to be welcome news for investors in the start-up given the string of worrying stories that have followed the company for the past few years, most recently the news that the company had mishandled hazardous waste. Questions remain, however, over the long-term efficacy and safety of the product.
Neuralink’s mission, according to its website, is to “Create a generalized brain interface to restore autonomy to those with unmet medical needs today and unlock human potential tomorrow.” Currently, this means implanting a brain-computer interface into patient’s skulls to allow them to operate computers and artificial limbs with their thoughts. Technology consultant Michael Orme said that if proven, the product, “can be deployed in principle to control any device while ushering in a true revolution for severely disabled people.”
29 January 2024
Philips ceases sales of sleep apnoea devices following FDA deal
Dutch company Philips has said it will halt sales of its sleep apnoea devices, according to the latest development regarding its troubled respiratory division. The move comes after an agreement, known as a so-called consent decree, was reached with the US Department of Justice, acting on behalf of the US Food and Drug Administration.
Philips set aside €363m ($393m) in Q4 2023 to deal with the issues around its devices, according to a 29 January press release. The company had previously taken a €575m provision in Q1 2023 to cover litigation costs of the faulty ventilator devices.
Shares in Philips opened 4% lower on Monday morning compared to the pre-announcement market Philips has endured a long saga with its Respironics business. Woes for the company began in 2021, when
Philips recalled certain devices following reports of polyester-based polyurethane foam breakdown, thereby potentially exposing patients to toxic chemicals. The company issued worldwide recalls for 15 million devices.close. The company is trading around 60% lower than pre-recall market highs in 2021.
26 January 2024
Abbott scores FDA approval for small, long lasting rechargeable DBS
Abbott has received approval from the US Food and Drug Administration (FDA) for its Libera RC deep brain stimulation (DBS) device.
The Liberta RC DBS system can be used to treat various movement disorders including Parkinson’s disease and essential tremors. The device is a small, rechargeable device that connects with Abbott’s proprietary NeuroSphere Virtual Clinic to allow for remote monitoring and programming for the Libera device.
The Liberta RC DBS system is approximately the size of a smartwatch. It needs about 10 recharge sessions in a year or 30-minute charging sessions every week when used under standard settings, as per Abbott. The device can be controlled either via an Abbott-supplied patient controller or a compatible and secure iOS device.
“When our patients choose a rechargeable DBS system, it is often based on the smaller size of the device, but the tradeoff has always been how recharge frequency affects their lifestyle,” said Dr. Paul Larson, professor of neurosurgery at the University of Arizona."
Ex-Aesculap employee sentenced to prison for falsifying FDA clearances
A former B.Braun-Aesculap employee that pleaded guilty to distributing medical devices without U.S. Food and Drug Administration (FDA) clearance has been sentenced to 12 months in prison.
In July of 2023, Peter Stoll III, pleaded guilty to one felony count of violating the Federal Food, Drug and Cosmetic Act (FDCA) after he created two false letters that purported to show that the FDA had granted clearance for Aesculap to sell its ELAN-4 Air Drill and SterilContainer JS Series devices.
On Tuesday 23 January, an Eastern District of Pennsylvania court sentenced Stoll to a 12-month custodial sentence, with an additional year of supervised release.
The US Department of Justice (DOJ) detailed how, in 2017, Stoll had been a regulatory affairs specialist for medical device manufacturer, Aesculap, where he was responsible for ensuring that Aesculap’s ELAN-4 Air Drill and SterilContainer JS Series made it through the FDA 510(k) clearance process.
25 January 2024
Shore Capital Partners and C2Dx acquire Cook Medical’s OHNS portfolio
Shore Capital Partners has teamed up with US-based device company C2Dx, to acquire Cook Medical’s family of Otolaryngology – Head and Neck Surgery (OHNS) products.
Cook’s OHNS products are used by ear, nose, and throat (ENT) surgeonsfor various conditions such as salivary disease, chronic ear disorders, nasal/sinus and skull base reconstruction, and dysphagia.
Products in the portfolio include salivary access and intervention tools, as well as its Biodesign Sinonasal repair graft designed for use during nasal and sinus mucosal tissue procedures.
The companies have not yet disclosed the value of the acquisition. In November of last year, CooperCompanies acquired $300m worth of medical devices from Cook, including minimally invasive Doppler monitoring, obstetrics, and gynaecology surgery devices. This deal came three months after CooperCompanies abandoned plans to acquire Cook Medical’s reproductive health business for $875m.