The UK government on Tuesday said it has issued legislation for the implementation of new regulations governing in vitro diagnostics and medical devices.

The total number of first-time registrations of Class II and III medical devices in 2023 was 14,942, a decrease of 129 registrations compared with that of 2022.

Illumina, Natera, CareDx, MDxHealth, and Revvity were among the molecular diagnostics and genomics tools firms reporting preliminary financial results on Monday evening or Tuesday morning.

GE HealthCare (Nasdaq: GEHC) today announced it has entered into an agreement to acquire MIM Software, a global provider of medical imaging analysis and artificial intelligence (AI) solutions for the practice of radiation oncology, molecular radiotherapy, diagnostic imaging, and urology at imaging centers, hospitals, specialty clinics, and research organizations worldwide. GE HealthCare expects to leverage MIM Software’s imaging analytics and digital workflow capabilities across various care areas to accelerate innovation and differentiate its solutions for the benefit of patients and healthcare systems around the world.

Chemiluminescence immunoassay reagent has become the mainstream product in the field of immunoassay and is widely used in clinical in vitro diagnosis due to its advantages such as high sensitivity, good specificity, a wide range of measurements, high degree of supporting automation, and excellent precision and accuracy.

Devyser Diagnostics AB has entered an in vitro diagnostic development agreement with Illumina, Inc. (Nasdaq: ILMN). The agreement enables Devyser to develop and offer its in vitro diagnostic (IVD) tests on Illumina MiSeqDx next-generation sequencing (NGS) instrument in the United States and Europe.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. Food and Drug Administration (FDA) clearance for the NeuMoDx CT/NG Assay 2.0, growing its test menu for its integrated PCR-based clinical molecular testing systems NeuMoDx 96 and 288 in the United States.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

The US Food and Drug Administration (FDA) has granted breakthrough device designation to CanScan, the multi-cancer early detection solution by Canadian medtech Geneseeq.

Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced it has signed an agreement with Janssen Research & Development, LLC (Janssen). This collaboration will be the first relating to the development of Illumina's novel molecular residual disease (MRD) assay, a whole-genome sequencing (WGS) multi-cancer research solution that detects circulating tumor DNA (ctDNA) to better understand the persistence or recurrence of disease following clinical intervention.

OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care and home diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, today announced it is leading the Series B financing and has entered wide-ranging strategic distribution agreements with Sapphiros, a privately held consumer diagnostics portfolio company based in Boston, and certain of its related entities. Sapphiros was conceived in 2020 by experienced healthcare executive Namal Nawana and launched along with leading global investment firm KKR in 2021. The company has since developed innovative capabilities including novel sample collection, next-generation detection systems, computational biology, and printed electronics to help consumers access diagnostic results.

Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today announced that it has received written notification from the staff of the Listing Qualifications Department of the Nasdaq Stock Market LLC (“NASDAQ”) dated December 29, 2023, indicating that for the last 30 consecutive business days, the closing bid price for the Company’s American depositary shares (the “ADSs”) was below the minimum bid price of US$1.00 per share requirement set forth in NASDAQ Listing Rule 5450(a)(1). The NASDAQ notification letter has no current effect on the listing or trading of the Company’s securities on NASDAQ.

Molecular diagnostic firm T2 Biosystems announced Wednesday that it has submitted a 510(k) premarket notification to the US Food and Drug Administration to expand the use of its T2Candida Panel for pediatric testing.

SEKISUI Diagnostics, a global medical diagnostics manufacturer, has formalized an exclusive distribution agreement with Aptitude Medical Systems (Aptitude™), an innovative developer of decentralized molecular diagnostics, to sell the Aptitude MetrixTM COVID-19 Test in the U.S. The Metrix test is currently the only EUA approved, molecular test which can be used with both swab and saliva samples and can performed by healthcare professionals or at home by consumers.

As of August 2023, the top three provinces in terms of the number of medical device manufacturers are Guangdong, Shandong and Hebei, with Guangdong ranking first with 8,493 medical device manufacturers. Chongqing has a total of 756 medical device manufacturing enterprises, ranking 19th in China.