The medical industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in numbers
$106.5
Medtronic must pay $106.5 million in a TAVI patent infringement lawsuit, a federal jury in California ruled.
$30m
Minerva Surgical announced that it closed a private placement worth approximately $30 million.
2.8%
Becton Dickinson reported a 2.8% decline in revenue to $4.58bn in the first quarter of the fiscal year 2023, from $4.71bn in the same quarter of the previous year.
Latest news
Globus Medical to acquire NuVasive for $3.1bn
Musculoskeletal solutions company Globus Medical has signed an agreement to acquire spine technology firm Nuvasive in an all-stock transaction valued at around $3.1bn.
According to the terms of the deal, shareholders of NuVasive will secure 0.75 of a share of Globus Medical Class A common stock for each owned share of NuVasive common stock after the closure of the transaction.
Upon completion of the deal, Globus Medical shareholders will hold a stake of around 72% in the combined company, on a completely dilutive basis, while NuVasive shareholders will own the remaining 28% interest.
Source: Medical Device Network
Abbott signs $890m deal to buy Cardiovascular Systems
Medtech giant Abbott has agreed to acquire the medical device company Cardiovascular Systems (CSI) in a deal valued at about $890m.
CSI is engaged in developing and commercialising interventional treatment systems for patients with peripheral and coronary artery disease.
The devices are designed for atherectomy, a marginally invasive treatment for plaque build-up that can restrict blood flow in patients’ arteries.
Furthermore, CSI is currently developing an early-stage pipeline of complementary vascular intervention devices.
Under the agreement, each CSI shareholder will receive $20 per share from Abbott.
Source: Medical Device Network
Novarad and Ikonopedia unite on next-generation breast imaging platform
Novarad has reached a partnership with Ikonopedia to offer a next-generation breast imaging platform to radiologists.
NovaMG Pro is a complete breast care platform that is claimed to feature an easy-to-use viewer as well as next-generation software for tracking and reporting. The combination of Ikonopedia’s modern cloud-based breast imaging reporting system and Novarad’s advanced viewing and image management technology is expected to provide radiologists with better breast imaging.
Ikonopedia offers a structured reporting tool for breast reporting. It uses advanced quality metrics alerts and reporting to reduce the number of wrong patient reports and incorrect laterality.
It provides radiologists with reporting excellence through QA notifications, shortcuts and automation.
Ikonopedia is claimed to enhance patient care by tracking each finding with full resolution.
Source: Medical Device Network
Regulatory
Ibex gets CE mark for Galen Prostate diagnostics platform
Ibex Medical Analytics has received a CE mark for its pathology diagnostics platform, Galen Prostate, under the European Union’s (EU) In Vitro Diagnostic Medical Devices Regulation (IVDR).
The new platform has been developed to help pathologists conduct a primary diagnosis of prostate biopsies.
It is claimed to be the first standalone artificial intelligence (AI) powered cancer diagnostics product of its type to be certified under the IVDR.
Source: Medical Device Network
FDA grants EUA to BD’s new molecular diagnostic combination test
The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Becton, Dickinson and Company’s (BD) new molecular diagnostic combination test for SARS-CoV-2, Influenza A + B and Respiratory Syncytial Virus (RSV).
Designed for use on the BD MAX molecular diagnostic system, the test uses a single nasal or nasopharyngeal swab sample to detect and differentiate whether a patient has Covid-19, the flu, RSV or a combination of the three.
The Respiratory Viral Panel for BD MAX System is an RT-PCR assay, which identifies and differentiates the nucleic acid of SARS-CoV-2, flu A, flu B and RSV within two hours for the first result.
Source: Medical Device Network
LumiraDx receives US and UK permits for Covid-19 and flu test
LumiraDx has secured US Food and Drug Administration (FDA) Emergency Use Authorization as well as UK Health Security Agency (UKHSA) validation for a multiplex test for Covid-19 and influenza A and B.
The multiplex Covid and influenza molecular test, named LumiraDx SARS-CoV-2 & Flu A/B STAR Complete assay, allows laboratories to quickly identify and differentiate individuals with respiratory viral infections consistent with Covid-19.
Clinical signs and symptoms of influenza and SARS-CoV-2 respiratory virus infections can be identical, making correct identification essential for treating patients, LumiraDx said.
Source: Medical Device Network
Nines
US-based company Nines is a tele-radiology and artificial intelligence startup. Its product NinesAI is FDA-cleared to triage time-critical, life-threatening indications of mass effect and intracranial hemorrhage.
Source: Nines
Lucira Health
Biotechnology company Lucira Health offers disposable at-home test kits to detect infectious diseases, such as Covid-19.
Source: Lucira Health
Bloomlife
US-based company Bloomlife is using technology, data science and medical expertise to address issues in maternal health.
Source: Bloomlife
