GE HealthCare Submits StarGuide GX for FDA 510(k) Clearance

Product / Tech
โดย Zacks Investment Research·US·Read original
Summary · why it matters

GE HealthCare Technologies Inc. has submitted its next-generation StarGuide GX digital 4D CZT SPECT/CT system to the FDA for 510(k) clearance, following recent CE Mark approval in Europe. The system, designed to support theranostics and precision care, aims to expand access to molecular imaging technologies. Jean-Luc Procaccini, president and CEO of Molecular Imaging and Computed Tomography at GE HealthCare, emphasized the company's focus on innovation to meet evolving healthcare needs. Following the announcement, GEHC stock fell 3% at yesterday's close, and year to date shares are down 18.6%, compared with the industry's 20.6% decline, while the S&P 500 has risen 11.6%. The regulatory progress could strengthen GE HealthCare's position in the molecular imaging market, which is projected to reach $9.5 billion by 2026 with a CAGR of 4.6% through 2030, according to Grand View Research.

Impact on stocks 7

Biotech & Genomic Medicine▲ · 4 stocks
Aging Population▲ · 1 stocks
Robotics & Physical AI▲ · 1 stocks
Defense & Geopolitical Fragmentation▲ · 1 stocks

Theme Impact 1

Related news

ChemoMetec Posts Record DKK511 Million Revenue, Guides FY26/27 to DKK545-575 Million

ChemoMetec reported record revenue of DKK511 million for its Q4 2026 fiscal year, up 3% year over year and 7% at constant exchange rates, with EBITDA rising 9% to DKK281 million and the EBITDA margin expanding to 55% from 52.1%. Instrument revenue grew 13% on the strength of XM products including NC-203, whose revenue jumped to DKK68.1 million from DKK27.7 million a year earlier, while the life science business, representing 95% of group revenue, grew 6% to approximately DKK485 million. Consumables revenue fell 4% on the US federal government shutdown in fall 2025, US and Canada revenue slipped 6% in reported terms, and the animal semen, beer and milk business dropped 32% amid a continued market exit. The company repurchased 105,000 shares at year-end for about DKK39 million and roughly 206,600 shares, or 1.2% of share capital, as of the call date, and ended with a cash position of approximately DKK290 million and equity of approximately DKK725 million. For FY2026/27, ChemoMetec guided revenue to DKK545 million to DKK575 million, implying roughly 7% to 13% growth, EBITDA to DKK300 million to DKK330 million, and CapEx to approximately DKK120 million, with CEO Martin Behrens saying the outlook excludes any contribution from the Roche, Tecan and Hamilton collaborations and from delayed XM orders.
0DZ0.LSE
Biotech & Genomic Medicine
GuruFocus·5hRead more →
▲

NAVER D2SF Backs ImpriMed in $10 Million Series A2 Bridge Round

NAVER D2SF, NAVER's in-house corporate venture arm, has invested in Silicon Valley precision medicine company ImpriMed, joining ImpriMed's $10 million Series A2 bridge round. The round was led by LB Investment, with participation from new investors NAVER D2SF, Samsung Securities, and Alois Ventures, plus follow-on investments from existing investors BonAngels and Han River Partners; it follows ImpriMed's $23 million Series A in 2023. ImpriMed combines ex vivo analysis of patient-derived live cancer cells with genomic, immunophenotypic, and clinical data through its xCellSense platform, and is developing AI models trained on more than 3.5 million data points. The company is preparing to commercialize products for blood cancers and blood infection, targeting FDA clearance and CLIA certification by Q1 2027 for an initial U.S. launch, while in South Korea its multiple myeloma prognosis and therapy-response software has been designated an Innovative Medical Device by the Ministry of Food and Drug Safety. ImpriMed was co-founded by CEO Sungwon Lim and CTO Jamin Koo, and its human healthcare expansion is supported by veterinary precision oncology work covering more than 27,000 tests for canine and feline lymphoma, used by over 600 veterinary hospitals across the United States, Canada, the United Kingdom, France, and South Korea.
016360.KO035420.KO1060.HK309960.KOCTO
Biotech & Genomic Medicine ▲
PR Newswire·15hRead more →

Avantor Expands RIM Single-Use Bioprocessing Portfolio Across APAC

Avantor has expanded the availability of its RIM single-use bioprocessing portfolio across the Asia Pacific region, strengthening its presence in a key biopharma manufacturing market. The portfolio includes single-use consumables such as bioprocessing bags, assemblies, tubing and components, plus mixing and storage hardware, and is manufactured at Avantor's Changzhou, China facility, the company's first single-use production site in APAC. That 2,600-square-meter plant operates under ISO 9001:2015 certification and Good Manufacturing Practice standards, and RIM products are available exclusively to APAC customers. The move aligns with management's broader Revival strategy, and in the second quarter of 2026 the Bioscience & Medtech Products segment posted double-digit order growth and a book-to-bill ratio of 1.1x, with management expecting the segment to return to organic growth in the second half of 2026. Avantor currently has a market capitalization of $10.56 billion, and its shares have gained 38.4% year to date versus 3.4% growth for the industry and a 10.1% rise in the S&P 500.
AVTR ▲
Biotech & Genomic Medicine
Zacks Investment Research·16hRead more →
© 2026 MarketDXNews