Medical Devices

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Flow Neuroscience launches FDA-cleared at-home tDCS device FL-100

Flow Neuroscience's FL-100 headset is now available by US prescription, becoming the first FDA-approved at-home tDCS treatment for moderate to severe
Flow Neuroscience's FL-100 headset is now available by US prescription, becoming the first FDA-approved at-home tDCS treatment for moderate to severe
The Biotech Times Editorial Team  · 
Digital Health
Medical Devices

NightWare wearable cuts nightmare distress in first responder study

A peer-reviewed pilot in Frontiers in Sleep found NightWare halved nightmare distress in San Francisco police and fire personnel with PTSD over 60 days.
A peer-reviewed pilot in Frontiers in Sleep found NightWare halved nightmare distress in San Francisco police and fire personnel with PTSD over 60 days.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics

Senseonics partners Beta Bionics to link Eversense 365 with iLet

Senseonics and Beta Bionics plan to integrate the year-long implantable CGM with the iLet Bionic Pancreas, targeting a commercial launch in Q4 2026.
Senseonics and Beta Bionics plan to integrate the year-long implantable CGM with the iLet Bionic Pancreas, targeting a commercial launch in Q4 2026.
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health
Diagnostics

Sonus Microsystems and Medtronic partner on AI wearable for preeclampsia

The Gates Foundation-funded collaboration will run field studies in Kenya, integrating Sonus's autonomous ultrasound patch with Medtronic's patient monitoring platform.
The Gates Foundation-funded collaboration will run field studies in Kenya, integrating Sonus's autonomous ultrasound patch with Medtronic's patient monitoring platform.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics
Digital Health

Magrabi Health spotlights Centres of Excellence at Forbes Riyadh summit

The Saudi specialist healthcare group used the Forbes Middle East Healthcare Summit 2026 to set out its expansion plans and tout a first-in-world
The Saudi specialist healthcare group used the Forbes Middle East Healthcare Summit 2026 to set out its expansion plans and tout a first-in-world
The Biotech Times Editorial Team  · 
Medical Devices

Elixir Medical wins Japan approval for DynamX coronary bioadaptor

Japan's MHLW has approved Elixir Medical's DynamX bioadaptor for coronary artery disease, creating a new device category in the country.
Japan's MHLW has approved Elixir Medical's DynamX bioadaptor for coronary artery disease, creating a new device category in the country.
The Biotech Times Editorial Team  · 
Medical Devices

Axogen prices $208.7m share offering to fund BioCircuit deal

Axogen is selling 4.91 million shares at $42.50 each, with proceeds earmarked to finance its pending acquisition of BioCircuit Technologies.
Axogen is selling 4.91 million shares at $42.50 each, with proceeds earmarked to finance its pending acquisition of BioCircuit Technologies.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics

Femasys partners CapexMD to finance FemaSeed fertility access

Femasys has linked with specialist fertility lender CapexMD to offer patients financing for its FemaSeed intratubal insemination portfolio across OB/GYN practices.
Femasys has linked with specialist fertility lender CapexMD to offer patients financing for its FemaSeed intratubal insemination portfolio across OB/GYN practices.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics
Digital Health

Nanox reports 37% revenue rise but takes $40.7m impairment charge

Nano-X Imaging grew Q2 revenues to $4.2m but recorded a $40.7m intangible asset impairment, widening its GAAP net loss to $55.5m.
Nano-X Imaging grew Q2 revenues to $4.2m but recorded a $40.7m intangible asset impairment, widening its GAAP net loss to $55.5m.
The Biotech Times Editorial Team  · 
Medical Devices

Precision Optics takes $1.3m defence follow-on order for micro-optics

The Littleton, Massachusetts firm said the order continues a programme running since 2018 and expects a long-term manufacturing agreement to follow.
The Littleton, Massachusetts firm said the order continues a programme running since 2018 and expects a long-term manufacturing agreement to follow.
The Biotech Times Editorial Team  · 
Medical Devices

SS Innovations reports 14,000+ procedures and telesurgery record

SS Innovations says its SSi Mantra system has surpassed 14,100 cumulative procedures and set a new longest-distance telesurgery record spanning 13,600 miles.
SS Innovations says its SSi Mantra system has surpassed 14,100 cumulative procedures and set a new longest-distance telesurgery record spanning 13,600 miles.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics

CooperCompanies retains CooperSurgical and lifts buyback to $3bn

CooperCompanies concluded its nine-month strategic review by keeping CooperSurgical and expanding its share repurchase programme by $1 billion.
CooperCompanies concluded its nine-month strategic review by keeping CooperSurgical and expanding its share repurchase programme by $1 billion.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics

Hexiris Ophthalmics to show OBi glaucoma data at five meetings

Hexiris Ophthalmics will present first-in-human OBi Core results across five European and North American ophthalmology meetings this autumn.
Hexiris Ophthalmics will present first-in-human OBi Core results across five European and North American ophthalmology meetings this autumn.
The Biotech Times Editorial Team  · 
Medical Devices
Pharmaceuticals
Digital Health

HOPE Therapeutics first to deploy Zeta Surgical's robotic TMS system

NRx subsidiary HOPE Therapeutics is training clinical staff on Zeta Surgical's FDA-cleared robotic TMS platform ahead of Florida deployment and a DARPA-backed
NRx subsidiary HOPE Therapeutics is training clinical staff on Zeta Surgical's FDA-cleared robotic TMS platform ahead of Florida deployment and a DARPA-backed
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health
Diagnostics

Circle CVI positions cvi42 for TAVR volume surge after CMS ruling

CMS has finalised expanded Medicare coverage for TAVR in asymptomatic aortic stenosis, and Circle CVI says its imaging platform is ready to absorb the expected
CMS has finalised expanded Medicare coverage for TAVR in asymptomatic aortic stenosis, and Circle CVI says its imaging platform is ready to absorb the expected
The Biotech Times Editorial Team  · 
Medical Devices

Intuitive meta-analysis backs da Vinci across 13 conditions

A 14-million-procedure meta-analysis in Annals of Surgery Open found da Vinci robotic surgery improved key perioperative outcomes versus laparoscopic and open approaches.
A 14-million-procedure meta-analysis in Annals of Surgery Open found da Vinci robotic surgery improved key perioperative outcomes versus laparoscopic and open approaches.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals
Medical Devices

Syncromune presents SYNC-T Phase 1 prostate data at CIRSE 2026

The Florida biotech reported an 87% overall response rate in a 15-patient Phase 1 study of its intratumoral immunotherapy platform in metastatic prostate cancer.
The Florida biotech reported an 87% overall response rate in a 15-patient Phase 1 study of its intratumoral immunotherapy platform in metastatic prostate cancer.
The Biotech Times Editorial Team  · 
Medical Devices

Health Textiles Nigeria begins PermaNet Dual net production

Vestergaard's new Lagos facility is Nigeria's first to manufacture dual-active ingredient insecticide-treated nets, targeting 10 million units a year.
Vestergaard's new Lagos facility is Nigeria's first to manufacture dual-active ingredient insecticide-treated nets, targeting 10 million units a year.
The Biotech Times Editorial Team  · 
Medical Devices

Axogen to acquire BioCircuit Technologies for $200m cash

Axogen is buying the maker of NerveTape, the first FDA-approved sutureless peripheral nerve repair device, in a deal expected to close in Q4 2026.
Axogen is buying the maker of NerveTape, the first FDA-approved sutureless peripheral nerve repair device, in a deal expected to close in Q4 2026.
The Biotech Times Editorial Team  · 
Biologics
Medical Devices
Regulatory Science

Biora Therapeutics to start first human trial of oral biologic capsule

The San Diego biotech plans a first-in-human study of its BioJet capsule delivering adalimumab orally, with data expected in early 2027.
The San Diego biotech plans a first-in-human study of its BioJet capsule delivering adalimumab orally, with data expected in early 2027.
The Biotech Times Editorial Team  · 
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