US FDA APPROVES ABBOTT’S APP FOR DIABETES MANAGEMENT
03 august | approvals
The US Food and Drug Administration (FDA) has approved the Abbott FreeStyle Libre 2 iOS application for checking glucose levels to manage diabetes.
The accessible and cost-effective sensor-based glucose monitoring app permits customers to read their glucose levels on compatible iPhones without requiring a reader.
It facilitates a complete digital offering for Abbott’s FreeStyle Libre 2 integrated continuous glucose monitoring system.
Indicated for use in adults, as well as children aged four years and above with diabetes, the new app can offer customised glucose data every minute for those who are using FreeStyle Libre 2 glucose sensors.
Users can scan the sensor with the app to access the present glucose reading and trend arrow, which provides an understanding of the impact food, exercise and other lifestyle factors can have on their diabetes.
The FreeStyle Libre app, through the LibreLinkUp app, can help caregivers monitor patients remotely and receive alarms in real-time. The LibreLinkUp app also enables easy sharing of glucose data obtained with the new app.
02 august | Approvals
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.
02 August | market data
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.
02 august | deals
MISONIX’S PROPOSED MERGER WITH BIOVENTUS FACES INVESTIGATION
Stockholder rights law firm Bragar Eagel & Squire has launched an inquiry into Bioventus’ proposed acquisition of therapeutic ultrasonic technology developer Misonix for a total consideration of $518m.
Bragar Eagel & Squire will investigate if the officers or directors of Misonix breached their fiduciary duties or violated the federal securities laws concerning the merger.
Last month, Bioventus signed into a definitive agreement to acquire Misonix in a cash-and-stock deal.
As per the terms of the deal, approved by the boards of directors of both companies, stakeholders of Misonix will get nearly $518m from Bioventus.
Misonix stockholders can choose either 1.6839 shares of Bioventus class A common stock or $28 in cash without interest for each share of Misonix they own.
On concluding the acquisition, the merged entity will work as Bioventus and will use the international strengths of both companies as a pure-play regenerative medicine and orthopaedics company.
30 JUly | deals
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.
30 july | technology
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.
30 july | Device development
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.
29 july | market data
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.
FDA APPROVES MEDTRONIC’S AI ALGORITHMS FOR CARDIAC MONITORING
The US Food and Drug Administration (FDA) has granted clearance to Medtronic’s two artificial intelligence (AI) algorithms for use with the LINQ II insertable cardiac monitor.
ORTHOFIX MEDICAL LAUNCHES FIBRE BONE-GRAFT SOLUTION
Orthofix Medical has launched its fiberFuse Strip, an advanced demineralised bone-graft solution containing cancellous bone.
The new fiberFuse Strip is a preformed bone-graft strip for posterior cervical, posterior lumbar and degenerative spinal procedures.
MEMED OBTAINS CE MARK FOR COVID-19 TOOL
Diagnostic solutions developer MeMed has obtained the European CE mark for its MeMed Covid-19 severity tool for predicting severe outcomes in patients.
The new host response technology checks for various proteins in a serum sample and uses machine learning to determine the risk that a Covid-19 patient is likely to experience severe outcomes.
BD ACQUIRES RESORBABLE POLYMER TECHNOLOGY MAKER TEPHA
Becton, Dickinson and Company (BD) has acquired resorbable polymer technology developer and manufacturer Tepha for an undisclosed amount.
Tepha’s Poly 4-hydroxybutyric acid or resorbable polymer technology will offer BD further potential for innovations to boost its surgical mesh portfolio’s growth.
PERKINELMER AGREES TO ACQUIRE ANTIBODY MAKER BIOLEGEND FOR $5.25BN
PerkinElmer has signed an agreement to acquire antibody and reagent maker BioLegend for nearly $5.25bn in cash and stock.
PerkinElmer noted that the acquisition, which is subject to some adjustments, will be its largest so far.