News in numbers

$19.8 bn

The UK medical device industry is set to reach $19.8 billion by 2030, according to recent analysis by GlobalData.

$9.4bn

The value of venture capital investments in the medical devices sector in Q4 2021, representing a 6% increase year-on-year, according to research by GlobalData.

2.7%

Globally, average health expenditure per capita is expected to grow at a compound annual growth rate of 2.7% from 2009 to 2024, according to the Organization for Economic Co-Operation and Development.

50%

Half the respondents in a GlobalData poll of medical industry professionals believe the UK’s ability to acquire the latest and safest medical devices will be disrupted after the Brexit transition period.

Latest deals

Medtronic to acquire medical technology company Affera for $925m

Medtronic has signed a definitive agreement to acquire medical technology company Affera in a $925m deal. The deal will bolster Medtronic’s spectrum of advanced cardiac ablation products and accessories.

Source: Medical Device Network

Illumina and Agendia partner to co-develop in vitro diagnostic tests for oncology

Illumina and Agendia have entered a multi-year collaboration to jointly develop in vitro diagnostic (IVD) tests for oncology testing as well as offer enhanced insights to breast cancer patients. The alliance aims to progress the use of next-generation sequencing for decentralised testing.

Source: Medical Device Network

Suneva Medical signs merger with Viveon Health

Suneva Medical has signed a definitive merger agreement with Viveon Health Acquisition to create a new regenerative aesthetics company. The combined company’s pro forma equity valuation is expected to be approximately $511m.

Source: Medical Device Network

Clinical trials

BiologyWorks’ trial of Covid-19 test matches lab results accuracy

Digital healthcare platform firm BiologyWorks has announced that its k(now) handheld molecular testing device showed 99.1% accuracy with RT-PCR lab test results in a substantive Covid-19 clinical trial. Conducted by Locus Medicus in Athens, Greece, the independent clinical study tested 330 asymptomatic and symptomatic Covid-19 patients.

Source: Medical Device Network

Tonix Pharmaceuticals begins subject enrolment in skin test trial

Tonix Pharmaceuticals has announced the enrolment of the first participant in a dose-finding clinical trial of its diagnostic skin test, TNX-2100 (SARS-CoV-2 epitope peptide mixtures for intradermal administration). The in vivo diagnostic skin test is designed to measure delayed-type hypersensitivity to the SARS-CoV-2 virus.

Source: Medical Device Network

JelikaLite's Cognilum obtains FDA breakthrough device designation 

JelikaLite has received breakthrough device designation from the FDA for its Cognilum system, a non-invasive therapeutic medical device designed to reduce autism spectrum disorder symptoms in paediatric patients. The FDA granted breakthrough device designation based on data obtained from a placebo-controlled, double-blind clinical study conducted in 30 paediatric patients.

Source: Medical Device Network

Nines

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.

Source: Nines

Lucira Health

Biotechnology company Lucira Health offers disposable at-home test kits to detect infectious diseases, such as Covid-19.

Source: Lucira Health

Bloomlife

US-based company Bloomlife is using technology, data science and medical expertise to address issues in maternal health.

Source: Bloomlife