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BioWorld - Monday, December 11, 2023
Breaking News: Topic alerts now available for all BioWorld subscribersBreaking News: Topic alerts now available for all BioWorld subscribersBreaking News: Topic alerts now available for all BioWorld subscribers
  • Biospectal Optibp smartphone app

    Biospectal receives CE mark for blood pressure monitoring app

    Biospectal SA has received a CE MDR class IIa medical device certification for its optical fingertip blood pressure monitoring app, Optibp. The device records fingertip blood flow optically and transforms the information into a pulse wave that it analyzes to estimate blood pressure.
  • Today's news in brief

    BioWorld MedTech briefs for December 8, 2023.
  • Biospectal receives CE mark for blood pressure monitoring app

    Biospectal SA has received a CE MDR class IIa medical device certification for its optical fingertip blood pressure monitoring app, Optibp. The device records fingertip blood flow optically and transforms the information into a pulse wave that it analyzes to estimate blood pressure.
  • Today's news in brief

    BioWorld MedTech briefs for December 8, 2023.
  • FDA facing a ‘somewhat unimaginable’ volume of applications for LDTs

    The U.S. FDA’s draft rule for lab-developed tests (LDTs) has proven to be every bit as controversial as expected, although the controversy is only marginally about the workload that would come with rulemaking.
  • ‘Oh when the government goes marching in’ a rising US threat?

    After a nine-month review, the Biden administration is preparing to go where all other U.S. administrations have refused to trod. In releasing a draft framework to help federal agencies decide whether to exercise a federal march-in on patent rights protecting taxpayer-supported drugs and other inventions, including medical devices.
  • Med-tech financings mark YOY decline, November sees more than $1B raised

    Med-tech financings surpassed $1 billion again in November, with transactions totalling $1.02 billion for the month. Though a decline from the $1.23 billion raised in October, the value is up from September’s $645.75 million.

BioWorld Insider Podcast

Six biopharma executives consider a tough 2023 and are hopeful for a better 2024.
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Digital health

  • SmartVibes app with Apollo wearable

    Apollo brings better sleep and stress relief with Smartvibes

    Neurology/psychiatric
    Apollo Neuroscience Inc. recently introduced a new software called Smartvibes for its Apollo wearable device to help people lower their stress levels and sleep better. There are a growing number of wearable technologies that have sensors that continuously measure physiological signals to help...
  • Vincentra Dexcom sensor and Diabeloop

    Vicentra launches hybrid closed-loop diabetes system

    Diabetes
    With hybrid closed-loop systems for automated insulin delivery increasingly being seen as life changing for people with diabetes, Vicentra BV has teamed up with Diabeloop SA and Dexcom Inc. to launch a system to help people with type 1 diabetes manage their condition.
  • Ausbiotech panelists explore digital health’s role in health care

    Asia-Pacific
    Digital health is on the cusp of transforming health care, and it’s not just about electronic health records, it’s about connecting medical devices with data and artificial intelligence and machine learning to improve health outcomes, panelists said during the Ausbiotech conference held in...
  • Dollar sign and Euro symbol in cogwheels

    Sofinnova raises $200M for digital medicine fund

    Financings
    Sofinnova Partners hauled in $200 million in investment for its digital health fund as investors’ appetite for companies developing solutions for health care using digital technology continues to grow.
More in Digital health

Today's news in brief

  • Appointments and advancements for Dec. 7, 2023

  • Financings for Dec. 8, 2023

  • In the clinic for Dec. 8, 2023

  • Other news to note for Dec. 8, 2023

  • Regulatory actions for Dec. 8, 2025

Regulatory

  • Abiomed warning letter for final deviation seen as opening salvo

  • FDA tells industry to get serious about UDI compliance

  • Neurostar TMS nets expanded approval in Japan

  • Post-pandemic inspection load an ongoing struggle for FDA

  • ACLA urges FDA to withdraw draft rule for lab-developed tests

  • FDA advisory panel sees need for registries for multi-cancer detection tests

  • FDA sends discordant signals with Global Harmonization Working Party withdrawal

  • Philips faces the heat with new thermal CPAP warning from FDA

  • Brainspec AI FDA cleared for noninvasive brain chemistry analysis

  • Bivacor pumped by FDA IDE approval for total artificial heart study

Financings

  • Hand holding piece of pie chart

    Intuitive Ventures raises $150M to support med-tech startups

    U.S.
    Intuitive Ventures, the investment arm of Intuitive Surgical Inc., closed a $150 million fundraising round for its second fund, which will focus on investments in startups in three areas: precision diagnostics and interventions, digital ecosystems and improving health care access and coordination....
  • Sofinnova launches AI platform to transform its investment approach

    Artificial intelligence
  • Bright Uro shines with $23M series A for Glean urodynamics system

    Urology
  • Awak’s AI model to predict CKD progression wins breakthrough label

    Regulatory
  • Asep, Sansure establish China sepsis diagnostics joint venture

    Asia-Pacific
More in Financings
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Newco news

  • Illustration of cell receptors, antibodies

    Etcembly aims at cancer with AI-driven, rapid TCR engineering technology

    Cancer
    Etcembly emerged from stealth mode in August with something it regards as seemingly impossible: A machine learning platform that has the ability to predict and engineer – at never-seen-before scale and speed – T-cell receptors (TCR) that enable bispecific T-cell engager antibodies targeting cancer...
  • Brainaurora files for Hong Kong IPO to develop digital therapeutics

    Financings
    Brainaurora Medical Technology Ltd. has filed for an initial public offering (IPO) in Hong Kong to develop its digital therapeutics for the treatment of cognitive impairment diseases. The company claims to be the first in China to launch a digital therapeutics (DTx) product for cognitive...
  • A born listener: CNS startup Violet hones in on cellular cross-talk

    Financings
    The identification of new targets in diseases of the central nervous system (CNS) such as Alzheimer’s and Parkinson’s – conditions which continue to have significant unmet needs – has taken a small step forward as one company, Violet Therapeutics Inc., plans to put $10.6 million in seed funding...
  • Flow Medical nears completion of catheter to treat venous thromboembolic disease

    Cardiovascular
  • Orakl developing in vitro diagnostic test using organoids for colorectal cancer

    Cancer
  • Startup Enhanc3D raises £10M for high-res genome mapping platform

    Medical devices and technologies
  • Spinoffs keep up dizzying pace with Medtronic separation

    U.S.
More in Newco news

Deals and M&A

  • Med-tech M&As continue decline while deal value soars nearly 50% YOY

    Analysis and data insight
    While med-tech deals were well below average the past two months, cumulative values are up 47.67% over the same period last year. Through October, the total worth of med-tech deals reached $9.97 billion, rising from $6.75 billion in the corresponding period in 2022.
  • Despite September slowdown, med-tech deal value hits $9.83B through Q3

    Analysis and data insight
    Med-tech deals are up 49.01% year over year, with the industry raising $9.83 billion through September in 2023, up from $6.59 billion in the same time frame last year. The number of deals, meanwhile, has decreased from 1,510 through Q3 2022 to 1,278 this year.
  • Regulatory icons

    EU orders Illumina to sell Grail or face further fines

    Regulatory
    The European Commission (EC) has ordered Illumina Inc. to sell Grail Inc. after it closed the acquisition without approval from EU regulators. The EC said that if Illumina fails to comply with the order, the company faces fines of up to 5% of its daily aggregate revenue or up to 10% of its annual...
  • Vaxxas HD-MAP

    SK Bioscience, Vaxxas partner to develop needle-free typhoid vaccine

    Infection
    SK Bioscience Co. Ltd.  and Vaxxas Pty. Ltd. have entered into a joint development agreement that could revolutionize vaccines by developing a vaccine-delivery device combination product using Vaxxas’ high-density microarray patch (HD-MAP) coupled with SK Bioscience’s typhoid vaccine, Skytyphoid.
  • No deal dice

    On the SPAC track: Slowdown continues with Ross/Aprinoia sputter

    Neurology/psychiatric
    The first special purpose acquisition company (SPAC) merger announced in 2023 has fallen apart. Aprinoia Therapeutics Inc. and Ross Acquisition Corp. II mutually agreed to call off the merger that had been valued at $280 million. The failed deal is part of a larger trend that has gained momentum in...
More in Deals and M&A

U.S.

  • First AID positions Dexcom for healthy new year

  • Inflammatix sepsis test scores FDA breakthrough device designation

  • Smith+Nephew steps up with $330M acquisition of Cartiheal

  • US FTC hits gene testing firm for claims related to ancestry testing

  • US FTC seeks yet more broad AI investigative authority

  • FDA clears 4dmedical’s CT lung ventilation analysis software

  • FDA cautions against Cardinal Health Monoject syringe use

  • FDA predetermined change control program major shift for med-tech

  • Medtronic rolls out Spyral in US after circuitous journey

  • MFDS leads global AI-based med device standardization effort

Europe

  • Jeremy Barande Ecole Polytechnique

    Omini develops blood testing platform for heart failure

    Cardiovascular
    Omini SA hopes that the multiplexed blood testing platform it is developing will transform the lives of patients suffering from heart failure. With its multiplex, sensor-based testing strip that simultaneously measures four key biomarkers from a single drop of blood, the company’s technology should...
  • A Google Maps for genomics: UK Biobank opens access to 15 years of genome sequencing data

  • Abtrace system predicts effects of intravenous fluid therapy for shock

    Patents
  • Gilde Healthcare closes fund at €740M

    Financings
  • Siemens focused on transforming Diagnostic business CFO says

    Conferences
More in Europe
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Asia-Pacific

  • eopatch2.jpg

    Medtronic scraps plans to buy wearable insulin patch maker Eoflow

    Drug design, drug delivery and technologies
    One of the largest med-tech deals of 2023 was wiped off the charts when Medtronic plc terminated a $738 million agreement to acquire South Korean wearable insulin patch maker Eoflow Co. Ltd., citing “multiple breaches” under its agreements, on Dec. 6.
  • Broncus acquires Chinese pulmonary device company Hangzhou Jiangliang

    Merger
    Broncus Holding Corp. subsidiary Broncus Hangzhou is acquiring Chinese medical device company Hangzhou Jingliang in the form of an equity transfer agreement for ¥5.4 million (US$758,000). The move will strengthen Broncus’ R&D capabilities in the flexible robotic space and will allow the company to...
  • Metal-enhanced fluorescence system quickly detects viral infections

    Infection
    South Korean researchers from the Gwangju Institute of Science and Technology (GIST) developed a new fluorescence-based lateral-flow immunoassay (LFI) enhanced with gold nanorod (GNR)-based probes to detect viral infections like the influenza A virus.
  • Polyactiva’s ocular implant shows sustained drug delivery for glaucoma

    Ophthalmic
  • Neurophet nets ₩20B from financing, slates Kosdaq IPO for 2024

    Financings
  • Fertilis improving IVF success rates with 3D printing and microfluidics

    Obstetrics
  • Yamaha Motors spins out antibody profiling company Tuning Fork Bio

    Diagnostics
More in Asia-Pacific

Clinical

  • Surmodics reveals positive data for its Sundance Sirolimus DCB

    Conferences
    Surmodics Inc. reported positive two-year data from the SWING trial, the first-in-human study to look at the safety of its Sundance Sirolimus drug-coated balloon (DCB) when used to treat occlusive disease of the infrapopliteal arteries. Results...
  • Xeltis’ vascular Axess graft implant sees no infection after one year

    Conferences
    One-year data from Xeltis AG’s first-in-human Axess vascular conduit trial showed outstanding results in patients with end stage renal disease who were deemed unsuitable for arteriovenous (AV) fistula creation. The results, presented at the...
  • Edwards, Medtronic likely to gain a beat on competition at TCT

    Conferences
    Medtronic plc got a jump on its cardiology competitors with big news ahead of the Transcatheter Cardiovascular Therapeutics (TCT) conference that starts on Oct 24 in San Francisco, with U.S. FDA approval of its Aurora extravascular implantable...
  • Humacyte’s phase II/III tissue graft data prompt talk of a BLA

    Immune
    Regenerative tissue developer Humacyte Inc. has posted positive top-line phase II/III results for its Human Acellular Vessel, a tissue-engineered graft consisting entirely of decellularized extracellular matrix, for vascular trauma repair. The...
  • Neuraxis looks beyond gut to apply IB-Stim in post-concussion syndrome

    Gastrointestinal

    Neuraxis Inc. has initiated a clinical study to evaluate the efficacy of its IB-Stim neuromodulation system in treating children with post-concussion syndrome (PCS). The aim is to see whether IB-Stim can ease the constellation of symptoms that...

  • EDEN trial shows DBS improves movement in stroke patients

    Medical devices and technologies
    A first-in-human clinical trial conducted by researchers at the Cleveland Clinic demonstrated that deep brain stimulation (DBS) applied to the dentate nucleus region of the cerebellum could help patients recover function in their upper extremities...
More in Clinical

BioWorld Insider Podcast

One-on-one with medical innovators

podcast microphone, sound waves on purple backgroundBreakthrough 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:

  • Six biopharma executives consider a tough 2023 and are hopeful for a better 2024
  • AI: driving drug development from effective to remarkable
  • The struggle is real: The first half of 2023 was an uphill climb
  • The biosimilars challenge to Humira revs up
  • Preventing opioid overdoses with a smart patch
  • Better times ahead for the biopharma sector? Could be, the new numbers say
  • Radiopharmaceuticals: The next big disrupter?
  • Cambrian carves out a new niche as it works to keep people from getting sick
  • Rethinking obesity: Fitness may be more directly linked to health than weight
  • Looking ahead to 2023: CEOs contemplate the new normal

View all

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