Medical Devices

Medical Devices
Biologics

Cuprina to acquire seven-clinic Singapore healthcare group for S$4m

Nasdaq-listed Cuprina is buying East Coast Podiatry and Orchard Clinic to integrate clinical delivery with its wound-care and collagen technologies.
Nasdaq-listed Cuprina is buying East Coast Podiatry and Orchard Clinic to integrate clinical delivery with its wound-care and collagen technologies.
The Biotech Times Editorial Team  · 
Medical Devices
Pharmaceuticals

SpyGlass Pharma buys AVS for $13m to lock in IOL supply

The Nasdaq-listed ophthalmic biotech has acquired its existing IOL manufacturer from Santen, securing Phase 3 supply and a route to premium lens options.
The Nasdaq-listed ophthalmic biotech has acquired its existing IOL manufacturer from Santen, securing Phase 3 supply and a route to premium lens options.
The Biotech Times Editorial Team  · 
Medical Devices

Nexalin Technology signs 10-year South America distribution deal

Nexalin Technology has appointed Inovanexa as exclusive distributor for its ANVISA-approved Sync neurostimulation device across seven Latin American countries.
Nexalin Technology has appointed Inovanexa as exclusive distributor for its ANVISA-approved Sync neurostimulation device across seven Latin American countries.
The Biotech Times Editorial Team  · 
Medical Devices

Integra LifeSciences cuts 2026 guidance after Cincinnati flood

Flooding at Integra's Ohio manufacturing site will cost up to $27m in lost revenue across Q3 and Q4, prompting a downgrade to full-year
Flooding at Integra's Ohio manufacturing site will cost up to $27m in lost revenue across Q3 and Q4, prompting a downgrade to full-year
The Biotech Times Editorial Team  · 
Medical Devices
Regulatory Science

Inspire Medical wins new CPT codes for its Inspire V device

New Category I CPT codes covering Inspire V's single-lead hypoglossal nerve stimulator are set to take effect on 1 January 2028.
New Category I CPT codes covering Inspire V's single-lead hypoglossal nerve stimulator are set to take effect on 1 January 2028.
The Biotech Times Editorial Team  · 
Medical Devices
Pharmaceuticals

Elutia receives $8m Boston Scientific escrow; funded into 2029

Elutia has cleared its final 2026 funding milestone, receiving the full $8m holdback from its BioEnvelope sale with no indemnity claims.
Elutia has cleared its final 2026 funding milestone, receiving the full $8m holdback from its BioEnvelope sale with no indemnity claims.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics

Autonomix Medical secures FDA support for 510(k) sensing platform

Autonomix Medical says FDA pre-submission feedback supports a Class II substantial-equivalence route, targeting clearance of its neural sensing platform in roughly 15
Autonomix Medical says FDA pre-submission feedback supports a Class II substantial-equivalence route, targeting clearance of its neural sensing platform in roughly 15
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health
Diagnostics

ViCentra Kaleido patch pump hits TIR targets in 3,918-patient study

Real-world data from nearly 4,000 European type 1 diabetes patients shows Kaleido met consensus time-in-range targets with median hypoglycaemia of just
Real-world data from nearly 4,000 European type 1 diabetes patients shows Kaleido met consensus time-in-range targets with median hypoglycaemia of just
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics
Pharmaceuticals

IBA to distribute ARTMS QIS cyclotron technology for theranostics

IBA will offer ARTMS's solid-target QUANTM Irradiation System to cyclotron customers worldwide, supporting local radiometal production for theranostics.
IBA will offer ARTMS's solid-target QUANTM Irradiation System to cyclotron customers worldwide, supporting local radiometal production for theranostics.
The Biotech Times Editorial Team  · 
Medical Devices

Wandercraft acquires Ekso Bionics to form global exoskeleton leader

Wandercraft's all-cash deal for Ekso Bionics creates a combined portfolio of four medical exoskeletons across rehabilitation and personal mobility markets.
Wandercraft's all-cash deal for Ekso Bionics creates a combined portfolio of four medical exoskeletons across rehabilitation and personal mobility markets.
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health
Diagnostics

Ceribell wins FDA clearance for qEEG trending on its AI platform

Ceribell's 510(k)-cleared software adds three quantitative EEG tools to its point-of-care platform, covering patients from premature neonates to adult ICU
Ceribell's 510(k)-cleared software adds three quantitative EEG tools to its point-of-care platform, covering patients from premature neonates to adult ICU
The Biotech Times Editorial Team  · 
Medical Devices

IBA to install first gantry proton therapy centre in central Italy

IBA has signed a contract with Rome's IFO to deliver a Proteus ONE proton therapy system, bringing gantry-based treatment to central and southern
IBA has signed a contract with Rome's IFO to deliver a Proteus ONE proton therapy system, bringing gantry-based treatment to central and southern
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics
Digital Health

CapsoVision wins FDA clearance for AI Highlights capsule endoscopy tool

CapsoVision's AI-assisted reading tool for its CapsoCam Plus system has received FDA clearance, following an earlier EU launch under MDR.
CapsoVision's AI-assisted reading tool for its CapsoCam Plus system has received FDA clearance, following an earlier EU launch under MDR.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Medical Devices
Regulatory Science

Crossject strengthens balance sheet as BARDA deal extended to $48m

The Dijon-based emergency-medicine biotech returned to positive equity after a €15m capital raise, with its BARDA contract now extended through 2030.
The Dijon-based emergency-medicine biotech returned to positive equity after a €15m capital raise, with its BARDA contract now extended through 2030.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Medical Devices
Regulatory Science

Crossject expands board and hires ex-FDA lead ahead of ZEPIZURE launch

The French specialty pharma firm has added three executives to its board and appointed a former FDA reviewer to lead US regulatory strategy for ZEPIZURE.
The French specialty pharma firm has added three executives to its board and appointed a former FDA reviewer to lead US regulatory strategy for ZEPIZURE.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics
Pharmaceuticals
Cell & Gene Therapy
Biologics

Penn Medicine and IBA form Noventra Oncology Alliance JV

The joint venture will offer end-to-end advisory and operational support to health systems building or expanding proton therapy programmes worldwide.
The joint venture will offer end-to-end advisory and operational support to health systems building or expanding proton therapy programmes worldwide.
The Biotech Times Editorial Team  · 
Medical Devices

Kessler Foundation and UPnRIDE partner on upright mobility study

Kessler Foundation and UPnRIDE are studying real-world use of the FDA-cleared standing mobility platform among rehabilitation patients.
Kessler Foundation and UPnRIDE are studying real-world use of the FDA-cleared standing mobility platform among rehabilitation patients.
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health

neurocare and Wave Neuroscience partner on EEG-guided PTSD therapy

The collaboration brings Wave Neuroscience's FDA-cleared MeRT system onto neurocare's Apollo TMS platform, targeting the 16 million Americans affected by PTSD.
The collaboration brings Wave Neuroscience's FDA-cleared MeRT system onto neurocare's Apollo TMS platform, targeting the 16 million Americans affected by PTSD.
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health
Diagnostics

Firefly and NeuroSigma partner to distribute FDA-cleared ADHD device

Firefly Neuroscience will introduce NeuroSigma's Monarch eTNS sleep-worn neurostimulator to its US clinician network as a non-drug ADHD option for children.
Firefly Neuroscience will introduce NeuroSigma's Monarch eTNS sleep-worn neurostimulator to its US clinician network as a non-drug ADHD option for children.
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health

Precision Neuroscience closes $250m Series D for BCI expansion

The New York BCI company raised an oversubscribed round co-led by Pershing Square, bringing total funding to $430m since its 2021 founding.
The New York BCI company raised an oversubscribed round co-led by Pershing Square, bringing total funding to $430m since its 2021 founding.
The Biotech Times Editorial Team  · 
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