Multi Radiance shines with FDA clearance for laser treatment of fibromyalgia
Millions of patients with fibromyalgia have battled widespread pain with few effective treatment options for decades. The U.S. FDA has offered reason for hope and better health with four recent decisions. On Oct. 4, Solon, Ohio-based Multi Radiance Medical Inc. (MRM) received clearance for its Fibrolux therapy laser for the condition, following Neurometrix Inc.’s de novo authorization for its transcutaneous electrical nerve stimulation device, Quell, in May. Remedee Labs SA received breakthrough device designation (BDD) for its endorphin stimulation system in May and Swing Therapeutics Inc. was granted BDD for its digital therapy in Aug. 2021.

Multi Radiance shines with FDA clearance for laser treatment of fibromyalgia
Millions of patients with fibromyalgia have battled widespread pain with few effective treatment options for decades. The U.S. FDA has offered reason for hope and better health with four recent decisions. On Oct. 4, Solon, Ohio-based Multi Radiance Medical Inc. (MRM) received clearance for its Fibrolux therapy laser for the condition, following Neurometrix Inc.’s de novo authorization for its transcutaneous electrical nerve stimulation device, Quell, in May. Remedee Labs SA received breakthrough device designation (BDD) for its endorphin stimulation system in May and Swing Therapeutics Inc. was granted BDD for its digital therapy in Aug. 2021.
White House blueprint for AI bill of rights hints at need for new enforcement legislation
The Biden administration has released a blueprint for an artificial intelligence bill of rights, which is accompanied by an acknowledgement that these algorithms can be crucial in guiding treatment of cancer patients.
FBI jumps into debate over medical device cybersecurity
The U.S. FBI is not typically seen as playing a meaningful role in medical device cybersecurity, but the agency recently released a report regarding unpatched and outdated medical devices, nonetheless. The report includes five recommendations to deal with these devices, but the agency gives no indication as to whether the report signals an interest in enforcement activities related to medical device cybersecurity.
Today's news in brief
BioWorld MedTech briefs for Oct. 5, 2022.
New technology providing good vibrations for stroke patients
A new prototype device that delivers barely perceptible vibrations to the fingertips has led to improvements of between 20% – 40% in patients who have lost their sense of touch following an ischemic stroke.
Brazil updates regulations for medical device registration
Anvisa, Brazil´s health care surveillance agency, issued new regulations for the registration of medical devices as it works to harmonize its own rules with international standards and integrate its medtech industry with those of other countries in the region.
Lumos’ 510(k) hopes for Febridx quashed with second FDA rejection
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. has had its hopes of entering the U.S. market dashed yet again following a second decision from the FDA that Febridx has not demonstrated substantial equivalence to the predicate device identified in its 510(k) application.

BioWorld Insider Podcast

BioWorld staff writer Lee Landenberger talks with James Lanthier, the CEO of Mindset Pharma, which is developing what it calls “next-generation” psychedelic medicines to treat neurological and psychiatric disorders.

Listen now

Digital health

NICE prods NHS to gather data for wearables used to track Parkinson’s
Europe
In a development that is a potential boon for wearables and other sectors of the digital health industry, the U.K.’s NICE has petitioned the National Health Service (NHS) to expand its coverage of devices that monitor patients with Parkinson’s disease. That data would be used by NICE to inform a...
Novo Nordisk wins first smart insulin pen approval for diabetes in China
Asia-Pacific
Novo Nordisk A/S received marketing approval from China’s NMPA for its smart insulin pen Novopen Six that automatically collects and stores the date and time of injections and the number of units of insulin that users take.
Home monitoring leads to lower death, rehospitalization rates for French HF patients
Europe
The association of health care professionals in Normandy (APRIC) and the regional support group for the development of e-health in Normandy released new data on the importance of home telemonitoring in heart failure. Patients participating in the Suivi Clinique à Domicile (SCAD) heart failure home...
AI detects anomalies responsible for epilepsy seizures
Neurology/Psychiatric
International research project Multicentre Epilepsy Lesion Detection (MELD), led by University College London, has developed artificial intelligence software that can identify minute brain anomalies that lead to epilepsy seizures. These anomalies, known as focal cortical dysplasia, can often be...

Financings

Vergent sees bright future for imaging agent with $21.5M fundraising round
Private
Vergent Bioscience Inc. raised $21.5 million in a series B financing round to advance development of VGT-309, its targeted fluorescent imaging agent that illuminates tumors during open, minimally invasive and robotic-assisted surgeries. The company plans to use the funds to support a phase II trial...

Newco news

Ampel’s genomic blood test detects and predicts severity of COVID-19
Coronavirus
As doctors and public health officials brace for a possible fall coronavirus surge, one of the challenges continues to be predicting who will have a mild, moderate or severe case of COVID-19.

Curimeta launches partnership to unlock real-world data
Financings
Startup Curimeta Inc. emerged from stealth with $6 million in seed financing led by Washington University School of Medicine in St. Louis and BJC Healthcare, a St. Louis-based nonprofit health care system. Cultivation Capital Healthcare Innovation Fund also participated in the round.
Biolab Sciences heals wounds with autologous gel-like graft
Dermatologic
Since its launch in the U.S. in April, Biolab Sciences Inc.’s Dermistat has facilitated the healing of 80 wounds using its unusual gel-graft formula. The product transforms a patient’s skin cells into a partial thickness skin graft in 48 hours and a full-thickness graft in five to seven days. The...

Deals and M&A

Getinge joins forces with Medtronic to launch Radiant stent for ChEVAR procedures in Europe
Getinge AB reported a partnership with Medtronic plc for the Radiant stent, the first covered stent indicated for chimney endovascular aneurysm repair (ChEVAR). This new balloon-expandable stent graft for renal arteries obtained CE mark approval on Sept. 20.
Rising med-tech deal volume and M&A values propelled by digital health
Analysis and data insight
The number of med-tech deals in 2022 are up by 18% over last year, and the value of mergers and acquisitions has climbed 11%.
MD Anderson Cancer Center, Radiopharm launch JV for radiopharmaceuticals
Cancer
The University of Texas MD Anderson Cancer Center and Radiopharm Theranostics Ltd. have launched Radiopharm Ventures LLC, a joint venture (JV) that will develop radiopharmaceutical therapies for cancer. Radiopharm Theranostics owns 51% of shares in the new entity, while MD Anderson owns 49%.
Advanced Medtech acquires Huikang Medical to strengthen presence in China
Acquisition
Urology device maker Advanced Medtech Holdings Pte. Ltd. acquired a majority interest in Shenzhen Huikang Medical Apparatus Co. Ltd., a urology and shockwave therapy devices provider.
Judge overrides FTC’s attempt to block Illumina’s acquisition of Grail
Diagnostics
An administrative law judge has decreed that the acquisition of Grail Inc., by Illumina Inc., would not represent a suppression of competition in the market for multicancer early detection (MCED) tests, clearing a way for an acquisition that was initially valued at more than $7 billion.

Europe

Precisis prepares for market launch of epilepsy pacemaker
Precisis GmbH is ready for market rollout after securing CE marking for its minimally invasive brain pacemaker for treating drug refractory epilepsy.

Asia-Pacific

Intuitive’s Da Vinci SP surgical system cleared for use in Japan
Japan
Japan’s Ministry of Health, Labour and Welfare (MHLW) has given Intuitive Surgical Inc. the green light for its Da Vinci SP surgical system. The surgical system has been cleared for use in general surgeries, thoracic surgeries (excluding cardiac procedures and intercostal approaches), urologic...

Olympus launches surgical energy device for open surgery in Japan
Japan
Olympus Corp. has launched the Thunderbeat Open Fine Jaw Type X surgical energy device in Japan to support safer open surgery procedures.
Koutech completes financing to develop robots for microsurgery
Financings
Koutech Medical Robotics (Shanghai) Co. Ltd. reported it has raised “hundreds of millions of yuan” in a series A round to support the development of its surgical robot. The round is led by Qiming Venture Partners.

Clinical

Dueling trials highlight differences between Amulet and Watchman LAA closure devices
Conferences
Boston Scientific Corp. and Abbott Laboratories continue to parry over clinical trials comparing the latter’s Amplatzer Amulet with Boston Scientific’s Watchman in sealing the heart’s left atrial appendage (LAA) to prevent ischemic stroke in...
Study validates Volta's AI mapping system for atrial fibrillation
Europe
Volta Medical SAS reported validation for its VX1 software mapping system, an artificial intelligence (AI) algorithm compatible with most commonly available multi-pole catheters and technology used in operating rooms and cath labs for treating...
Veracyte deciphers the conundrum of aggressive prostate cancer in African American men
U.S.
Aggressive prostate cancer disproportionately affects—and kills—African American men, but identifying which men are at highest-risk has proved challenging, particularly in younger patients. Veracyte Inc.’s Decipher prostate genomic classifier...
Late-breaking trials at TCT provide good news for major med-tech device companies
Analysis and data insight
The 2022 Transcatheter Cardiovascular Therapeutics annual meeting highlighted mostly positive outcomes from major trials conducted by nearly all the big players in the cardiac device market. Here’s our round-up of the meeting’s high points, with...
Encouraging outcomes for Medtronic’s Evolut as research shows challenges with SAVR after TAVR
Conferences
Transcatheter aortic valve replacement (TAVR) continues to grow, so it is little surprise that the 2022 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting featured multiple presentations about TAVR-related devices and outcomes. The...
Medtronic and Recor show durable blood pressure reduction with renal denervation
Conferences
In an unexpected turn of events, Medtronic plc presented results from the Symplicity HTN-3 trial at year 3 showed sustained reductions in blood pressure with radiofrequency renal denervation (RDN) for resistant hypertension, contrary to the...

BioWorld Insider Podcast

One-on-one with medical innovators

podcast microphone, sound waves on purple background Breakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.

Recent episodes:

View all

BioWorld

The news source of record covering the development of innovative human therapies for 25+ years

BioWorld MedTech

Actionable and timely intelligence on advances in medical devices and technologies for 20+ years

BioWorld Asia

A weekly monitor of biopharmaceutical news from the industry’s fastest-growing region

BioWorld Science

Essential discovery and preclinical research news to support crucial drug R&D decisions at the earliest stages

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription

Today's news in brief

BioWorld

BioWorld MedTech

BioWorld Asia

BioWorld Science

BioWorld Premium