Conor Hale

Washington, D.C.

Senior Editor at Fierce Biotech

Writing and reporting on medical developments for @FierceMedTech and @FierceBiotech

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Articles

Roche to spend $550M building Indianapolis HQ into CGM production hub

2 days ago | fiercebiotech.com | Conor Hale

Roche plans to invest as much as $550 million in its Indianapolis diagnostics campus during the next five years, with plans to build it into a U.S. manufacturing and distribution hub for its wearable diabetes blood sugar sensors.
Capsule endoscopy developer CapsoVision files $30 million IPO

3 days ago | fiercebiotech.com | Conor Hale

CapsoVision has filed to go public, with plans to raise up to $30 million to support the development of its swallowable capsule camera and screening programs for gastrointestinal diseases, cancers and internal bleeding.
FDA approves Teal Health’s HPV screening test as an at-home alternative to the Pap smear

6 days ago | fiercebiotech.com | Conor Hale

The FDA has approved its first at-home collection kit that allows women to screen themselves for human papillomavirus and cervical cancer risk by mailing a sample to a lab—where it is analyzed by the same Pap smear test used in clinics. Developed by Teal Health, the Teal Wand is available with a prescription. It uses a sponge-like swab to gather a sample from within the vagina, with no speculum required.
Imperative Care launches dual-catheter stroke aspiration system

6 days ago | fiercebiotech.com | Conor Hale

Following the FDA’s clearance earlier this year of its large-bore catheter for removing oxygen-blocking blood clots, Imperative Care is rolling out a new technique for treating stroke that combines two of its systems. The company said its Zoom DuoPort approach enables uninterrupted aspiration during thrombectomy by connecting two catheters to a single vacuum source dubbed the continuous dual aspiration technique, or CDAT.
FDA appoints first chief AI officer as it looks to speed up reviews

1 week ago | fiercebiotech.com | Conor Hale

The FDA has appointed its first chief artificial intelligence officer, with an eye on supporting the agency’s internal IT systems and potentially accelerating its reviews of medical products. Jeremy Walsh was named head of IT and AI, according to his post on LinkedIn. The move was first reported by Politico. Walsh previously held the role of chief technologist at Booz Allen Hamilton, managing AI- and cloud-based projects for 14 years at the consultancy.
Roche launches fibrosis blood test for gauging liver disease severity

1 week ago | fiercebiotech.com | Conor Hale

Roche is rolling out a new diagnostic test to help assess hidden liver fibrosis in patients showing signs of metabolic dysfunction-associated steatotic liver disease, or MASLD. The company said its 18-minute Elecsys PRO-C3 blood test, run on its cobas e instruments, is used alongside a formula that accounts for other clinical information—such as the patient’s age, diabetes status and platelet count. Its findings can help guide treatment and potentially provide access to upcoming therapies.
GE HealthCare rolls out new AI-equipped SPECT/CT nuclear medicine scanner

1 week ago | fiercebiotech.com | Conor Hale

GE HealthCare has obtained the FDA’s blessing for its latest imaging system combining SPECT and CT scanning, as well as for the artificial intelligence programs that help power it. The Aurora nuclear medicine system’s dual-head design, which integrates gamma ray-based SPECT hardware alongside X-ray CT components, expands its range of procedures across multiple specialities. Meanwhile, the Clarify DL deep learning AI works to boost image coherence and reduce noise.
Masimo reports cyber attack slowing manufacturing, sales

1 week ago | fiercebiotech.com | Conor Hale

Masimo disclosed that a cyber attack on its systems has hit its manufacturing facilities, slowing production at the remote patient monitoring company. In a filing with the SEC alongside its quarterly earnings report, Masimo said that—while the investigation remains ongoing, and its full scope and impacts are unknown—the company believes the intrusion has not affected its cloud-based hospital data systems, and it said there’s currently no evidence of employee or patient data being compromised.
FDA elevates intraocular lens recall as Bausch + Lomb identifies cause

1 week ago | fiercebiotech.com | Conor Hale

The FDA elevated a recall of intraocular lenses currently being wrapped up by Bausch + Lomb, following increased reports of inflammatory reactions from patients who underwent cataract surgery. The company first announced it would begin pulling certain models of its enVista implants in late March and early April, including its Aspire and Envy toric and non-toric lenses, as well as monofocal versions.
Abbott’s rapid blood-based concussion test is off to the races

1 week ago | fiercebiotech.com | Conor Hale

Abbott’s rapid, blood-based test for concussions is making its sporting debut through the motorcycle racing series MotoAmerica, marking the first professional organization to deploy the screener at its competitions. The cartridge-based test for mild traumatic brain injuries—which claimed an expanded clearance from the FDA last year—runs on Abbott’s hand-held i-STAT Alinity instrument and is designed to deliver a result within 15 minutes.