US FDA APPROVES NUVASIVE’S PULSE PLATFORM FOR SPINE SURGERIES

NuVasive has announced the receipt of US FDA 510(k) approval as well as the commercial launch of its Pulse platform for spine surgeries.

The move follows the receipt of CE mark approval for the latest design update of the platform, which was secured in June.

Pulse is an integrated technology platform designed to increase the safety, efficiency and procedural reproducibility of spine surgery.

It integrates radiation reduction, imaging enhancement, navigation, intraoperative neuromonitoring, patient-specific rod bending, wireless connectivity and spinal alignment tools into a single platform.

This enables surgeons to easily access multiple technologies from a compact footprint, as well as address a number of common surgical challenges.

Clinical evidence shows that the Pulse platform has helped surgeons reduce operating room time, time under anaesthesia, intraoperative risks and length of hospital stays as well as saving hospital costs.

SIEMENS REPORTS ROBUST REVENUE GROWTH IN Q3 2021

Siemens Healthineers has reported a 38.9% rise in revenue on a comparable basis to $5.93bn (€5bn) in the third quarter (Q3) of the fiscal year (FY) 2021, compared to $3.92bn (€3.31bn) in the same quarter last year.

For the quarter ended 30 June 2021, adjusted EBIT rose 103% to $1.12bn (€945m) as against $552m (€465m) in Q2 FY2020. This indicates a robust adjusted EBIT margin of 18.8%, induced by development in the diagnostics segment.

Net income in the quarter increased 46% to $469m (€395m), from $322m (€271m) in Q3 of FY2020.

Siemens recorded an 84% growth in the adjusted basic earnings per share to $0.66 (€0.56) in Q3 of this FY compared to $0.37 (€0.31) in the prior-year quarter.

Furthermore, the equipment book-to-bill ratio, or the ratio of new orders to revenue, stood at 1.18 in Q3 of this year.

During the quarter, free cash flow was $1.01m (€852m), representing a 154% increase, versus $399m (€336m) in Q3 of FY2020.

BAXTER ACQUIRES PERCLOT ASSETS FROM CRYOLIFE

Baxter International’s Baxter Healthcare subsidiary has acquired certain assets related to PerClot Polysaccharide Hemostatic System from CryoLife in a deal valued at up to $60.8m.

The transaction includes $25m paid upfront, with the remainder to be paid after the achievement of certain select milestones.

Of the total amount, CryoLife will receive up to $45.8m and Starch Medical (SMI) will receive the remaining $15m.

Additionally, CryoLife and SMI agreed to end their existing PerClot licensing and supply agreements.

Under the deal, Baxter acquired the PerClot product line along with the worldwide marketing rights, customer relationships, intellectual property and equipment.

Baxter stated that the acquisition marks its entry into the global hemostatic powder segment, as well as the expansion of its advanced surgery portfolio to include a wider range of active and passive solutions.

CEPHEID’S TWO HIV-1 TESTS OBTAIN CE-IVD CLEARANCE

Cepheid has obtained CE-IVD clearance for two advanced, extended-coverage (XC) human immunodeficiency virus (HIV) tests, Xpert HIV-1 Viral Load XC and Xpert HIV-1 Qual XC.

Xpert HIV-1 Viral Load XC is indicated for analysing the viral load levels that are used for monitoring the antiretroviral treatment efficiency.

It adds a second target for the identification of HIV-1, offering expanded strain coverage to boost performance and alleviate the risk of false-negative results because of gene mutations or deletions.

Xpert HIV-1 Qual XC also adds a second target for quicker detection of HIV-1 infections, up to seven to ten days before seroconversion.

This test is intended to be used in both laboratory and near-patient testing environments for adults, adolescents and infants.

ABBOTT LAUNCHES INSERTABLE CARDIAC MONITOR FOR ABNORMAL HEART RHYTHMS

Abbott has unveiled its new insertable cardiac monitor (ICM), Jot Dx, in the US to enhance precise diagnosis of abnormal heart rhythms, which are hard to detect, and lower data burden.

To aid doctors and hospitals in managing the data flow, the Jot Dx ICM has a feature to see either all abnormal heart rhythm information or select the irregular heart rhythms to be recorded using a ‘key episodes’ option.

This technology facilitates the detection of cardiac arrhythmia remotely and enhances the preciseness of patient diagnosis.

Jot Dx ICM tracks the cardiac rhythms of patients continuously. The device can be directly connected through Bluetooth to a mobile app, myMerlin, which can send data to doctors and patients in real time.

THERMO FISHER REPORTS 34% GROWTH IN Q2 2021 REVENUE

Thermo Fisher Scientific has reported a 34% rise in revenue to $9.27bn in the second quarter (Q2) of this year, compared to $6.92bn in the same quarter last year.

Organic revenue in Q2 2021 increased 28%, with Covid-19 response revenue standing at $1.9bn.

For the three months ending 3 July 2021, GAAP diluted earnings per share (EPS) rose 59% to $4.61, as against $2.9 in Q2 2020.

Adjusted EPS in the second quarter of 2021 increased 44% to $5.60, versus $3.89 in the second quarter of 2020.

During the quarter, adjusted operating income was $2.69bn versus $1.86bn in the prior-year quarter, representing a 44% increase, and the adjusted operating margin stood at 29%, as against 27% last year.