Medical Devices

Medical Devices

Iridex MicroPulse TLT shows sustained IOP cuts in two-year study

An independent Italian study found MicroPulse transscleral laser therapy reduced intraocular pressure by 37% over 24 months across early to advanced glaucoma.
An independent Italian study found MicroPulse transscleral laser therapy reduced intraocular pressure by 37% over 24 months across early to advanced glaucoma.
The Biotech Times Editorial Team  · 
Medical Devices
Regulatory Science

SeaStar Medical secures ICD-10-PCS codes for SCD kidney therapy

New billing codes active from 1 October 2026 streamline hospital reimbursement for QUELIMMUNE and could accelerate adoption in paediatric AKI.
New billing codes active from 1 October 2026 streamline hospital reimbursement for QUELIMMUNE and could accelerate adoption in paediatric AKI.
The Biotech Times Editorial Team  · 
Medical Devices
Pharmaceuticals

Beyond Air posts record $2.3m quarter as LungFit PH adoption grows

Beyond Air said Q3 2026 revenue rose 30% sequentially to $2.3m, its highest ever, while its second-generation nitric oxide system awaits FDA approval.
Beyond Air said Q3 2026 revenue rose 30% sequentially to $2.3m, its highest ever, while its second-generation nitric oxide system awaits FDA approval.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics
Pharmaceuticals

Profound Medical and Telix link up on PSMA-PET and MRI prostate care

The two commercial-stage companies will co-educate physicians on combining PSMA-PET imaging with Profound's MRI-guided TULSA-PRO ablation platform.
The two commercial-stage companies will co-educate physicians on combining PSMA-PET imaging with Profound's MRI-guided TULSA-PRO ablation platform.
The Biotech Times Editorial Team  · 
Medical Devices

Stryker names Spencer Stiles CEO as Kevin Lobo moves to Executive Chair

Stryker's 27-year veteran Spencer Stiles will become CEO on 1 January 2027, as Kevin Lobo transitions to Executive Chair after tripling annual revenues.
Stryker's 27-year veteran Spencer Stiles will become CEO on 1 January 2027, as Kevin Lobo transitions to Executive Chair after tripling annual revenues.
The Biotech Times Editorial Team  · 
Medical Devices
Biologics

Vascudyne lab-grown bypass vessel sustains flow at two-year mark

The Minnesota biotech presented two-year clinical patency data for its acellular bioengineered coronary graft at the EACTS Annual Meeting in Barcelona.
The Minnesota biotech presented two-year clinical patency data for its acellular bioengineered coronary graft at the EACTS Annual Meeting in Barcelona.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics

NeuroOne joins Dartmouth NIH grant for neurotransmitter sensing

NeuroOne will receive around $200,000 from a $1 million NIH BRAIN Initiative grant to co-develop real-time neurotransmitter sensing with Dartmouth College.
NeuroOne will receive around $200,000 from a $1 million NIH BRAIN Initiative grant to co-develop real-time neurotransmitter sensing with Dartmouth College.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Medical Devices

MannKind presents Furoscix ReadyFlow PK/PD data at HFSA 2026

New analyses support IV-equivalent diuresis from MannKind's autoinjector, cleared by the FDA in July 2026 for outpatient fluid management in heart failure and
New analyses support IV-equivalent diuresis from MannKind's autoinjector, cleared by the FDA in July 2026 for outpatient fluid management in heart failure and
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics
Digital Health

Spectral AI files NTAP application for DeepView burn-wound system

Spectral AI has applied to CMS for additional Medicare reimbursement for its AI-powered DeepView burn-wound imaging device, cleared by the FDA in May
Spectral AI has applied to CMS for additional Medicare reimbursement for its AI-powered DeepView burn-wound imaging device, cleared by the FDA in May
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health
Biotech

Al Ghurair launches Trellis Health hospital network in Dubai

The UAE conglomerate's new healthcare group opens a 50-bed multi-speciality hospital in Umm Suqeim, with two further clinics due by end of
The UAE conglomerate's new healthcare group opens a 50-bed multi-speciality hospital in Umm Suqeim, with two further clinics due by end of
The Biotech Times Editorial Team  · 
Medical Devices
Regulatory Science

Manchester-led team maps path for virtual patients in device regulation

A University of Manchester-led consortium has published a framework for using computer-simulated patients to support medical device regulatory decisions.
A University of Manchester-led consortium has published a framework for using computer-simulated patients to support medical device regulatory decisions.
The Biotech Times Editorial Team  · 
Medical Devices

Spirair publishes six-month Vayu Study data for SeptAlign implant

Peer-reviewed results show a 63% reduction in nasal obstruction scores at six months, with no serious adverse events recorded across 75 patients.
Peer-reviewed results show a 63% reduction in nasal obstruction scores at six months, with no serious adverse events recorded across 75 patients.
The Biotech Times Editorial Team  · 
Medical Devices

Iantrek reports 37% IOP reduction in bio-reinforced canaloplasty study

Six-month first-in-human data showed a 37% drop in intraocular pressure and no serious adverse events across 52 treated eyes.
Six-month first-in-human data showed a 37% drop in intraocular pressure and no serious adverse events across 52 treated eyes.
The Biotech Times Editorial Team  · 
Medical Devices

MMI raises $125m Series D to scale Symani robotic microsurgery

Medical Microinstruments secured the oversubscribed round to expand its Symani Surgical System globally, with around 50 systems installed and 3,500 procedures completed.
Medical Microinstruments secured the oversubscribed round to expand its Symani Surgical System globally, with around 50 systems installed and 3,500 procedures completed.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Medical Devices

GenSight optogenetic therapy safe and restores object detection

A first clinical cohort of ten blind retinitis pigmentosa patients showed meaningful light sensitivity gains with GenSight's gene therapy and goggle system.
A first clinical cohort of ten blind retinitis pigmentosa patients showed meaningful light sensitivity gains with GenSight's gene therapy and goggle system.
The Biotech Times Editorial Team  · 
Medical Devices
Biologics

TISSIUM begins US enrolment in UNITE hernia fixation trial

TISSIUM has treated its first US patients with the ECLIPSIUM System in a 240-patient IDE trial comparing non-penetrating mesh fixation against resorbable tacks.
TISSIUM has treated its first US patients with the ECLIPSIUM System in a 240-patient IDE trial comparing non-penetrating mesh fixation against resorbable tacks.
The Biotech Times Editorial Team  · 
Medical Devices
Pharmaceuticals
Regulatory Science

Kaléo wins $96m BARDA contract for 2-PAM nerve agent auto-injector

The Virginia biotech secured a Project BioShield award to advance its pralidoxime auto-injector through FDA approval and initial stockpile procurement.
The Virginia biotech secured a Project BioShield award to advance its pralidoxime auto-injector through FDA approval and initial stockpile procurement.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics
Regulatory Science

SeaStar Medical wins seventh Breakthrough Device tag for SCD in sepsis

The FDA designation covers hyperinflammation in adult sepsis patients, a population with no currently approved immunomodulatory therapy.
The FDA designation covers hyperinflammation in adult sepsis patients, a population with no currently approved immunomodulatory therapy.
The Biotech Times Editorial Team  · 
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