The medical industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in numbers
The number of medical devices gaining approval in the US in June 2022 saw a 20% decrease when compared with May 2022, GlobalData data shows
The 3D printed medical device market is anticipated to reach $4.5 billion by 2026, at 13% annual growth rate, as per a Business Research Company report
The number of consultation responses received by the Medicines and Healthcare products Regulatory Agency (MHRA) on proposed changes to the regulatory framework for medical devices in the UK
One estimate of how often intensive care unit clinicians are alerted by a medical device alarm in every eight-hour shift
The market value of key medical devices in China will surpass $42 bn in 2022, according to GlobalData
Over 285,000 medicines and medical devices seized UK-wide in global action
Medicines and medical devices valued at over £850,000, totalling more than 285,000 items, have been seized by officers from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as part of a global operation to tackle the illegal sale of medical products, with UK seizures estimated to be worth around 9% of the global total.
Biotronik agrees to pay $12.95m to settle allegations of improper payments to physicians
Biotronik, a medical device manufacturer based in Oregon, has agreed to pay $12.95m to resolve allegations that it violated the False Claims Act by causing the submission of false claims to Medicare and Medicaid by paying kickbacks to physicians to induce their use of Biotronik’s implantable cardiac devices, such as pacemakers and defibrillators.
Source: US Department of Justice
US FDA adds AEDs and other medical devices to shortage list
The US FDA added automated external defibrillators (AEDs), chest drains/suction canisters, and autotransfusion systems to its list of medical devices in short supply.
AEDs – including wearable and nonwearable versions of the devices – are expected to be in limited supply for at least the rest of 2022, the FDA said. The agency cited both an increase in demand for AEDs and the global shortage of semiconductors used in the devices.
Source: Medical Design & Outsourcing
Synchron completes first US human implant of brain-computer interface rivaling Elon Musk’s Neuralink
Synchron announced today that it completed the first-in-human brain-computer interface (BCI) implant in the US. The procedure, performed at Mount Sinai West in New York, represents the first such implant to occur in the US using an endovascular BCI approach, which does not require invasive open-brain surgery.
Dr. Shahram Majidi, assistant professor of neurosurgery, neurology and radiology at the Icahn School of Medicine at Mount Sinai, led the procedure, which was performed in the angiography suite with a minimally invasive, endovascular approach.
It was the first patient implant in Synchron’s Command trial, operating under FDA investigational device exemption to assess a permanently implanted BCI.
Source: Mass Device
That’s a wrap: BioCircuit seals up FDA clearance for surgical nerve-repairing tape
When a peripheral nerve is injured or severed and requires surgery to repair, the standard treatment involves manual suturing of the nerve’s outer connective tissue, a somewhat complex process that requires close precision and intense focus.
The nerve repair process just got a lot simpler, however, thanks to a new FDA 510(k) clearance (PDF) for a device that essentially amounts to a piece of Scotch tape that can quickly and effectively rejoin nerve ends.
With the agency’s go-ahead, Nerve Tape is now on track to make its US clinical debut sometime in 2023, according to BioCircuit Technologies, which developed the device in partnership with Virginia Commonwealth University’s Orthopedic Microsurgery Laboratory.
Source: Fierce Biotech
Explained: What India’s draft medical devices Bill says – and what it does not
India’s Union Health Ministry released a draft of a proposed The Drugs, Medical Devices and Cosmetics Bill, 2022 to replace the existing The Drugs and Cosmetics Act, 1940, and several sets of Rules by which the industry is currently run.
The draft focuses on regulating medical devices as a separate entity, makes provision for fines and imprisonment for injury and death related to clinical trials or investigations, and seeks to regulate e-pharmacies.
What else is new in the proposed draft Bill?
One is that the draft Bill makes provisions for compensation to participants or their legal heirs for injury or death suffered in clinical trials and investigations for drugs and medical devices.
Source: The Indian Express
US-based company Nines is a tele-radiology and artificial intelligence startup. Its product NinesAI is FDA-cleared to triage time-critical, life-threatening indications of mass effect and intracranial hemorrhage.
Biotechnology company Lucira Health offers disposable at-home test kits to detect infectious diseases, such as Covid-19.
Source: Lucira Health
US-based company Bloomlife is using technology, data science and medical expertise to address issues in maternal health.