Social Media Ideas for Fda Breakthrough Device

United Therapeutics nabs FDA approval for donor-lung assessment device

United Therapeutics has been given a premarket approval from the FDA for its LungFX device.

HepQuant nabs FDA premarket approval for liver diagnostic test

The FDA has granted premarket approval to HepQuant’s liver diagnostic test for the treatment of adults with Child-Pugh Class A compensated cirrhosis, according to a company press r...

SpinaFX Medical receives FDA Investigational Device Exemption (IDE) for Triojection®, its Breakthrough, Minimally-Invasi...

The prospective, randomized, multicenter trial will compare intradiscal ozone/oxygen injection plus nerve root block to nerve root block…

IHealthScreen nabs FDA nod for AI-backed dx to spot mild diabetic retinopathy

IHealthScreen hauled in FDA 510(k) clearance for its AI-powered diagnostic that detects mild diabetic retinopathy in diabetic adults who have gone undiagnosed with the condition.

FDA Clears First Neurostimulation Device for PTSD

Neurovalens’ Modius Spero has become the first FDA-approved neuromodulation device for treating PTSD symptoms. Veterans are set to gain access through the VA this summer. The post...

FDA drops blood pressure device enforcement against Whoop

The FDA has sent an End of Enforcement notice to consumer wearable device company Whoop, putting a formal end to the agency’s investigation into its blood pressure tech use.

FDA Grants De Novo Clearance to Burn Wound Assessment System

The AI-based imaging system is designed to help clinicians assess burn wound healing potential and identify wounds that may require intervention.

This Ear-Based Device Could Save Patients from Brain Bleed Complications

Aurenar’s V-Link, a non-invasive nerve stimulation device for preventing brain hemorrhage complications, just won FDA breakthrough device designation after early trials showed it c...

FDA Breakthrough Therapy and RMAT: Strategic Decisions That Can Accelerate Oncology Development

Explore how FDA Breakthrough Therapy and RMAT designations can create opportunities for oncology programs when backed by the right development strategy.

SpinaFX Medical receives FDA Investigational Device Exemption (IDE) for Triojection®, its Breakthrough, Minimally-Invasi...

SpinaFX Medical's prospective, randomized, multicenter trial will compare intradiscal ozone/oxygen injection plus nerve root block to nerve root block alone in 300 patients in up t...

Solenic MedicalВ® Receives FDA IDE Approval to Initiate Pivotal Trial of SOLA-2в„ў for Periprosthetic Joint Infections

Solenic Medical today announced that the FDA has approved the its IDE application, authorizing the launch of a pivotal clinical trial for its SOLA-2в„ў Alternating Magnetic Field S...

<![CDATA[FDA Sends CRL to Cingulate for CTx-1301]]>

Neurovalens gets US FDA approval for PTSD treatment device

Other devices developed by the Northern Irish company for the treatment of insomnia, anxiety and weight management have previously received various levels of FDA approval. Read mo...

FDA warning slams Zoll Medical with multiple quality control and reporting violations

Zoll Medical, the maker of devices and software focused on cardiopulmonary and respiratory conditions, was slammed in an FDA warning letter that outlined numerous quality control a...

Winter Innovations Receives FDA 510(k) Clearance and PCCP Authorization for Expanded EasyWhip® Family

Winter Innovations announced that the FDA has granted 510(k) clearance for the expanded EasyWhip® Family, along with authorization of a Predetermined Change Control Plan (PCCP) cov...

CMS Announces RAPID Coverage Pathway to Speed Medicare Coverage of New Medical Devices

The Gap Between FDA Authorization and Medicare Coverage In April 2026, the Centers for Medicare & Medicaid Services (“CMS”) and the U.S. Food and Drug Administration (“FDA”) an...

Orthopedic Driven Imaging Announces FDA 510(k) Clearance for HipGuide™ — Its First FDA-Cleared Surgical Imaging App

SurGenTec® Receives FDA Clearance for ION-L™, a Novel Lumbar Facet Fixation System Representing a Paradigm Shift in M...

SurGenTec® today announced FDA clearance of its ION-L™ Lumbar Facet Fixation System. ION-L™, indicated for the treatment of patients with (DDD) from L3 to S1 in skeletally mat...

FDA Issues Draft Guidance Clarifying Use of Form FDA 3542

FDA clears Dexcom’s Stelo OTC glucose monitor for use with children

The FDA gave the green light to Dexcom’s over-the-counter glucose monitor Stelo for children 2 years or older who don’t use insulin.

Production problems hamper Lantheus bid for FDA approval of radiopharma dx kit

The FDA dealt Lantheus’ bid to garner approval of its radiodiopharmaceutical diagnostic kit a setback due to manufacturing issues at a third-party facility.

<![CDATA[FDA’s New Pilot Program and Real-Time Review of Clinical Data]]>

Penumbra’s THUNDERBOLT Receives FDA Clearance – Bringing Computer Assisted Vacuum Thrombectomy Technology to Stroke

THUNDERBOLT is the first CAVT platform to deliver modulated aspiration for acute ischemic stroke — enabling faster, more…

Guardant Health nabs FDA test approval to find patients for Boehringer’s new cancer drug

Boehringer Ingelheim’s Hernexeos has nabbed a companion diagnostic from Guardant Health after the FDA cleared its liquid biopsy test, Guardant360 CDx.